<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04454931</url>
  </required_header>
  <id_info>
    <org_study_id>2019-19093093-01</org_study_id>
    <nct_id>NCT04454931</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Endotracheal Suctioning Applied at Different Head Heights on the Oxygenation of the Brain</brief_title>
  <official_title>Evaluation of the Effect of Endotracheal Suctioning Applied at Different Head Height on Oxygenation of the Brain by Non-Invasive Method in Intensive Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zonguldak Bulent Ecevit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zonguldak Bulent Ecevit University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order for the brain, which is the most metabolically active organ of our body, to maintain&#xD;
      its functions, it must reach oxygen saturation in the best way with continuous and rich blood&#xD;
      flow.&#xD;
&#xD;
      Neurosurgery patients are followed for a while in the intensive care unit with a mechanical&#xD;
      ventilator. During the care of the patient in mechanical ventilation; position changes, head&#xD;
      height, endotracheal aspiration, oral care and invasive procedures that cause painful stimuli&#xD;
      to the patient are factors that can affect brain perfusion pressure and oxygenation status of&#xD;
      brain cells. It is known that high intracranial pressure, especially during and after&#xD;
      endotracheal aspiration application, causes serious conditions in patients by disrupting&#xD;
      cerebral blood flow.&#xD;
&#xD;
      It is also seen that cerebral blood flow is associated with head and body positions given in&#xD;
      the postoperative period. It is stated in the literature that neurosurgical patients should&#xD;
      be 30-45 degrees for proper head height in bed. In these patients, the height of the head&#xD;
      should be in a suitable position for the correction of cerebral blood flow, which&#xD;
      deteriorates during endotracheal aspiration, since autoregulation mechanisms are impaired or&#xD;
      always activated. However, when the literature is examined, no information about the ideal&#xD;
      head height that should be given to patients during endotracheal aspiration was found.&#xD;
&#xD;
      In addition, one of the most important parameters indicating the presence of cerebral&#xD;
      complications is monitoring of cerebral oxygenation. It is stated that the most appropriate&#xD;
      follow-up for patients should be evaluated by nurses in a non-invasive method.&#xD;
&#xD;
      In this study; In neurosurgery intensive care patients, endotracheal aspiration will be&#xD;
      applied during endotracheal aspiration at head heights of 15, 30 and 45 degrees and it is&#xD;
      aimed to determine the most appropriate head height during and after application by&#xD;
      monitoring non-invasive cerebral oximeter device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although the brain is only 2% of body weight,it is the most metabolically active and vital&#xD;
      organ of the body.Cells in the brain; they need higher amounts of oxygen and energy than&#xD;
      other organs in the body. Therefore, in order to maintain brain functions,rich and continuous&#xD;
      blood flow and optimal oxygen saturation are required. Cerebral blood flow(SKA) is the most&#xD;
      important factor in nutrition that provides oxygen saturation. Cerebral blood flow;Cerebral&#xD;
      perfusion pressure(SPB) is affected by mean arterial pressure(MAP) and intracranial&#xD;
      pressure(KIB).Under normal conditions, while SPB is constant, the conditions affecting blood&#xD;
      pressure and cerebral venous return and elevation of KIB affect SPB.While normal cerebral&#xD;
      blood flow is 50-70 ml/100 g/tissue/min;In cases where blood flow is interrupted,serious flow&#xD;
      disruptions occur in cerebral circulation when the flow rate drops below 20 ml and vital&#xD;
      conditions such as cerebral ischemia occur.&#xD;
&#xD;
      In cerebral blood flow intensive care patients;it may be disrupted during some maintenance&#xD;
      procedures that cause painful stimuli such as position change,head height,endotracheal&#xD;
      suctioning,oral care, and invasive procedures.In the literature;It is reported that if the&#xD;
      cerebral blood flow drops below 20 ml/100 g/min for 30 minutes,it will reversibly stop the&#xD;
      function of neurons,and if it falls below 10 ml/100 g/min for 30 minutes, irreversible neuron&#xD;
      damage will occur.Therefore, in order to prevent unwanted cerebral ischemia in intensive care&#xD;
      patients;Before each procedure applied to the patient, the amount of oxygen in the&#xD;
      bloodstream circulating in the brain tissue should be constantly monitored. In the last guide&#xD;
      published by the Brain Trauma Association;It is recommended that partial carbon dioxide&#xD;
      pressure(PaCO2) is 35-40 mmHg, partial oxygen pressure(PaO2) is above 60 mmHg, and arterial&#xD;
      oxygen saturation is 90% and above.In order to preserve these values, the patients are&#xD;
      followed up in the mechanical ventilator for a while in the first period they exit the&#xD;
      operation.&#xD;
&#xD;
      While the fact that the patients are connected to the mechanical ventilator may provide&#xD;
      advantage in terms of providing continuous oxygenation,it may bring additional risks for the&#xD;
      patients. Because the endotracheal suctioning suctioning need arises in the patient in the&#xD;
      mechanical ventilator.There are important risks of endotracheal suctioning of mechanically&#xD;
      ventilated patients with artificial in patients receiving mechanical ventilator support to&#xD;
      prevent hypercarbia and hypoxia caused by secretion accumulated in the respiratory&#xD;
      tract.These risks include hypoxia, arrhythmia, increase in&#xD;
      MPD,hypertension,hypotension,agitation,pain,etc. countable.Especially during endotracheal&#xD;
      suctioning, the increase of intracranial pressure in the patient, then the cough reflex&#xD;
      induced and the high course of intracranial pressure after suctioning will disrupt cerebral&#xD;
      perfusion,thus oxygenation of the brain is endangered.While blood flow and perfusion may be&#xD;
      normal before and during the procedure,it changes to critical value afterwards and if it&#xD;
      lasts more than 30 minutes,it poses a threat to patients.The position of the patient and the&#xD;
      length of stay in the same position affect the cerebral circulation,reducing SPB.In this&#xD;
      case,if the nursing follow-ups are insufficient or the attempts to protect the SME are&#xD;
      ineffective;it becomes difficult for the brain to perform its functions, and even becomes&#xD;
      unable to perform.&#xD;
&#xD;
      In the intensive care units,raising the head and positioning is a routine nursing initiative&#xD;
      in order to protect patients from KIB and cerebral complications that may occur due to&#xD;
      KIB.Different head heights and body positions applied after the neurosurgical intervention&#xD;
      have been observed to affect secondary complications by affecting SME, PB and SKA.According&#xD;
      to researches; lateral position given by raising the head of the bed, long-term flexion and&#xD;
      extension of the head, the head being constantly 45° high are positions that may be harmful&#xD;
      for neurosurgical patients.In addition, it has been reported that rotating or repositioning&#xD;
      causes more secondary brain damage(7%) by increasing the ICU compared to other nursing&#xD;
      interventions applied to patients. Secondary brain damage may result from 5 minutes after&#xD;
      nursing interventions or more than 10 minutes from the beginning of nursing intervention,20&#xD;
      mmHg above KIB,60 mmHg below SPB,and 100 mmHg below systolic blood pressure. Responsibility&#xD;
      of neurosurgical nurses;It is the safest way to provide the care that the patient needs&#xD;
      without experiencing any undesirable side effects and secondary complications (respiratory&#xD;
      events,cerebral ischemia,increased ICP,arrhythmia, etc.).This is directly related to the&#xD;
      quality of the treatments. The results of the research showed that nurses should follow the&#xD;
      cerebral oxygenation with non-invasive technique by constantly moving away from the invasive&#xD;
      methods that cause many complications such as infection,arrhythmia,vascular injury to&#xD;
      patients in the neurosurgery intensive care unit.&#xD;
&#xD;
      Since the oxygenation status of intensive care patients is measured and monitored with a&#xD;
      pulse oximeter,the hypoxia state occurring in oxygenation in the brain tissue cannot be&#xD;
      detected early. Standard methods used in the measurement of cerebral oxygenation have&#xD;
      significant limitations in these patients.Jugular venous bulb oximetry measurement is an&#xD;
      expensive method that requires invasive procedure;there is a risk of many complications such&#xD;
      as infection on the patient, risk of tissue integrity deterioration,vascular injuries during&#xD;
      bleeding of the catheter,bleeding; assessment of the measurement is essential by&#xD;
      neurosurgeons;In addition, this method may miss regional ischemia.Non-invasive techniques&#xD;
      such as transcranial doppler ultrasonography or electroencephalography(EEG) are other methods&#xD;
      used indirectly to assess the adequacy of cerebral blood flow or the presence of&#xD;
      ischemia.However,transcranial doppler and EEG are difficult to interpret by non-specialists.&#xD;
      Cerebral oximetry device that measures oxygenation of the brain;It is important because it is&#xD;
      a non-invasive method that monitors changes in cerebral oxygen metabolism,can provide&#xD;
      continuous at the bedside, provides accurate and precise results as well as invasive&#xD;
      methods,can provide nurses the convenience of interpretation independently in order not to&#xD;
      cause secondary complications in nursing applications.Therefore,it can be easily evaluated in&#xD;
      terms of nurses who are able to provide reliable and real-time data from several areas of the&#xD;
      brain simultaneously, which is effective for the prevention and early detection of secondary&#xD;
      injuries such as re-bleeding, vasospasm,cerebral ischemia,cerebral edema and seizure,and for&#xD;
      24 hours of patients.Cerebral oximetry device that works with near infrared&#xD;
      spectroscopy(NIRS) technology,which can be used as a bedside monitor, is considered to be the&#xD;
      most suitable device for patients and healthcare workers.&#xD;
&#xD;
      Studies have argued that low values in cerebral oximetry follow-ups may be predictors of&#xD;
      hypoxic ischemic damage.In feasibility studies for the use of NIRS technology of&#xD;
      neurocognitive and neurological complications during and after cardiac surgery;According to&#xD;
      the transcranial doppler device of the cerebral oximeter device in adult patients;The use of&#xD;
      this device has been suggested due to its advantages such as easy and uncomplicated&#xD;
      use,clear,undoubtedly identifiable brain oxygenation, and nurses can evaluate&#xD;
      independently.In studies, low regional regional oxygen level(rSO2) was directly and&#xD;
      significantly interpreted with poor results after brain injury. In one study, the measurement&#xD;
      of cerebral oxygen and hemoglobin values after vasospasm after subarachnoid hemorrhage was&#xD;
      done with transcranial doppler and NIRS and its correlation with cortical ischemia was&#xD;
      examined. Transcranial doppler failed to detect vasospasm in four of the six cases, while&#xD;
      NIRS detected changes in the brain cortex and basal vessels.In the study,it was reported that&#xD;
      a decrease of 3.9-6.4% compared to the basal value occurring in regional oxygenation was&#xD;
      cut-off values predicting high sensitivity(100%) and specificity(85.7%) vasospasm.&#xD;
&#xD;
      When the literature is examined; Evidence that cerebral oxygenation monitoring is important&#xD;
      in preventing complications such as delayed cerebral ischemia is clear. However, there is no&#xD;
      evidence of the head height to be given during endotracheal suctioning and how long the head&#xD;
      should remain in this position by affecting cerebral blood flow and KIB,which plays an&#xD;
      important role in oxygenation of the brain.In a study,it is desired that the head height of&#xD;
      neurosurgery patients should be 30 ° in terms of cerebral perfusion and should not exceed the&#xD;
      45 degree angle. Ledwith et al. (2010) also reported that the head height of 30 degrees in&#xD;
      the supine position decreases CRB. Coşkun et al. (2011), in patients with cerebral vascular&#xD;
      disease who did not undergo surgical intervention, they observed tracheal suctioning with a&#xD;
      head height of only 15 and 30 degrees, and an increase in cerebral blood flow with a head&#xD;
      height of 15 degrees in the measurement performed with transcranial doppler 5 minutes after&#xD;
      the applicationWhen the intracranial pressure is continuously high for more than 30 minutes,&#xD;
      SPB will deteriorate and the cerebral flow will be interrupted.In randomized controlled&#xD;
      studies,it has been reported that adequate cerebral perfusion is provided at head heights up&#xD;
      to 15 degrees and 60 degrees, but the ideal head height specified as 15° and 60° is very it&#xD;
      remained uncertain in a wide range. In the results of the meta-analysis study, it was&#xD;
      reported that the most suitable head height in terms of serabral perfusion was 30 and 45&#xD;
      degrees from 0,15,30 and 45 degrees in patients who underwent neurosurgery. However,it has&#xD;
      been emphasized that the results related to the ideal head height are still contradictory in&#xD;
      situations related to position change and other applications. In one study, when the head&#xD;
      height was reduced from 30 degrees to 0 degrees in patients with head injuries, when the&#xD;
      cerebral perfusion change was measured with NIRS technology; Cerebral perfusion pressure&#xD;
      showed a significant change during the reduction of head height (p &lt;0.001) and it was&#xD;
      observed that the level of cerebral perfusion and oxy-hemoglobin increased by decreasing the&#xD;
      head height. Although medical and nursing studies on this subject are still continuing today,&#xD;
      there is no study investigating the effect of the ideal head height that should be within 30&#xD;
      minutes required for stabilization of cerebral perfusion and oxygenation during and after&#xD;
      endotracheal suctioning.&#xD;
&#xD;
      There are no studies on the use of NIRS technology in nursing applications for neurosurgical&#xD;
      patients. Brogan et al. (2017) 's systematic review and metaanalysis study; It was emphasized&#xD;
      that studies examining the benefits of this technology in patients with traumatic brain&#xD;
      injury are insufficient, and that both doctors and nurses should prove the benefits of this&#xD;
      technology before and inside the hospital by conducting experimental research. In a study in&#xD;
      which cost analysis was performed in patients who were followed up using NIRS technology;It&#xD;
      was determined that there was an average decrease of 1937 dollars per patient (p=0.036) and&#xD;
      it was pointed out that NIRS is a sensitive and reliable monitoring tool that eliminates the&#xD;
      need for special nursing care. In line with these results,it is predicted that the nurses who&#xD;
      are with the patient for 24 hours and who participate in the care and treatment of the&#xD;
      patient can provide significant benefits for the patient by using this technology.With the&#xD;
      simple use of this technology by nurses in intensive care settings, it is aimed to prevent&#xD;
      many problems that may occur in patients and it is also thought that it will be&#xD;
      cost-effective in patients with long hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To monitor the change of endotracheal suctioning in cerebral oxygenation parameter with non-invasive monitor in neurosurgery intensive care patients and to look at the statistical significance of the change.</measure>
    <time_frame>The measurement will start with recording the value before the endotracheal suctıonıng application and end with recording the value at 30 minutes after the application. Results will be determined after reporting at the end of 1 year.</time_frame>
    <description>Preservation of neurosurgical patients' cerebral perfusion is very important for the prognosis of patients. It is known that endotracheal aspiration,which is one of the nursing care practices applied in the intensive care follow-up of these patients,impairs the cerebral perfusions.However, although it is known, it is not sufficient to monitor the parameters showing the srebral perfusion status by the nurses who are constantly present with the patient.This parameter will be monitored with the regional oximeter device,which is considered to be the most accurate and appropriate method during and after endotracheal aspiration,which is one of the applications that change the cerebral perfusion status the most.In the literature, follow-up up to 30 minutes was planned, as the time required to correct cerebral perfusion was reported as 30 minutes in these patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To look at the effect of using technology for early diagnosis of complications such as cerebral ischemia in neurosurgery intensive care patients.</measure>
    <time_frame>1 year</time_frame>
    <description>Changes in cerebral oxygenation may be an early sign of delayed complication of cerebral ischemia. Therefore, it is important to monitor the change in cerebral oxygenation. However, it is important that the best approach for monitoring this parameter is that patients can be monitored and evaluated by non-invasive healthcare professionals nurses, who are uninterrupted with the patients without leaving the intensive care environment. Therefore, the widespread use of such devices, which have proven their validity and reliability by using technology, suggests that the prognosis of the patients will have a good effect. Clinical research is needed for this. For this reason, in this group, which is a risky group, it is necessary to benefit from the technologies that non-invasive methods can be used without moving patients from their beds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of endotracheal aspiration on 15% head height in cerebral oxygenation in neurosurgery intensive care patients.</measure>
    <time_frame>1 year</time_frame>
    <description>Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 15 degrees of head height. Therefore, this is one of the results of this research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of endotracheal aspiration procedure applied at 30 degree head height on the percentage of cerebral oxygenation in neurosurgery intensive care patients.</measure>
    <time_frame>1 year</time_frame>
    <description>Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 30 degrees of head height. Therefore, this is one of the results of this research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of endotracheal aspiration on 45% head height in cerebral oxygenation in neurosurgery intensive care patients.</measure>
    <time_frame>1 year</time_frame>
    <description>Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 45 degrees of head height. Therefore, this is one of the results of this research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of age,gender,diagnosis, number of hospitalization days,mechanical ventilatory mode, glaskow coma scale score variables on patients' cerebral oxygenation before and after endotracheal suctionıng in patients with mechanical ventilation</measure>
    <time_frame>1 year</time_frame>
    <description>Personal characteristics of the harvests related to the sociodemographic health status affect the general condition of the patients. The effect of endotracheal aspiration procedure applied to patients on cerebral oxygenation varies depending on these variables. Examining the direction of this effect is among the results of the research.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Nurse's Role</condition>
  <condition>Endotracheal Aspiration</condition>
  <arm_group>
    <arm_group_label>Intensive care patients who underwent neurosurgery</arm_group_label>
    <description>Cerebral oxygenation status will be monitored during and after endotracheal suctioning in each patient included in the study. Non-invasive regional oximetry probes are placed in the frontal region of the patient and the patient will be positioned at the head height of 15 degrees with a 3-motor angle determining bearing system. Then, when the patient's need for endotracheal suctioning arises, endotracheal suctioning will be performed and the cerebral oxygenation status before the procedure, 1 minute, 5 minutes and 30 minutes after the procedure will be recorded on the monitor of the non-invasive regional oximeter device operating with NIRS technology. The same procedure will be applied to the patient at head heights of 30 and 45 degrees. Cerebral oxygenation status measured at each head height will be compared with appropriate statistical methods and the most appropriate head height will be determined.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Root® with O3® Regional Oximetry</intervention_name>
    <description>May help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.&#xD;
It was aimed to determine the appropriate head height that should be given to patients in order to correct the endotracheal suctioning sequence, which is the most important care application of the neurosurgery patients who are followed up in the intensive care unit after surgery, and the possibility of subsequent disruption of cerebral perfusion. Therefore, cerebral oxygenation status, which is the most important parameter that shows the cerebral perfusion status of patients during and after the application, will be followed up by nurses with a non-invasive cerebral oximeter device.</description>
    <arm_group_label>Intensive care patients who underwent neurosurgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Turkey linked to the Health Ministry in the Western Black Sea Region Zonguldak Ataturk&#xD;
        State Hospital intensive care unit treatment and care made postoperative mechanical&#xD;
        ventilation due to brain surgery all the patient population of the study (according to&#xD;
        information from the hospital's information-processing unit 01.01.2018- An average of 520&#xD;
        patients underwent brain surgery between 31.12.2018). The sample of the research, according&#xD;
        to the research results obtained from the literature; α = 0.05, 0.25 effect size was&#xD;
        determined as 46 patients with 90% power. The research was designed to make repeated&#xD;
        measurements in a single group. Patients who meet the inclusion criteria will be included&#xD;
        in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having undergone neurosurgery surgery,&#xD;
&#xD;
          -  To get mechanical ventilator support,&#xD;
&#xD;
          -  To have completed at least 6 hours in the mechanical ventilator, but not yet in the 72&#xD;
             hours,&#xD;
&#xD;
          -  Being at the age of 18 and over,&#xD;
&#xD;
          -  Life signs are stable (arterial blood pressure 160/90 mmHg; heart rate 70-100 / min,&#xD;
             respiratory rate 16-20 / min, body temperature 36-37.5 ° c) and no pulmonary problems,&#xD;
             Oxygen saturation level measured by pulse oximeter to be 85% and above,&#xD;
&#xD;
          -  Glaskow Coma Score (GKS) not being below 9E,&#xD;
&#xD;
          -  Na +, K +, Cl-, Hb, Hct values are within the normal reference range,&#xD;
&#xD;
          -  Not having contraindications for head and body positioning,&#xD;
&#xD;
          -  Volunteering to participate in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having another surgery apart from neurosurgery surgery,&#xD;
&#xD;
          -  Not getting mechanical ventilator support,&#xD;
&#xD;
          -  The time spent in the mechanical ventilator is less than 6 hours and more than 72&#xD;
             hours,&#xD;
&#xD;
          -  Being under the age of 18,&#xD;
&#xD;
          -  Life signs are unstable and have a pulmonary problem,&#xD;
&#xD;
          -  Oxygen saturation level measured by pulse oximetry below 85%&#xD;
&#xD;
          -  To be under Glaskow Coma Score (GKS) 9E,&#xD;
&#xD;
          -  Na +, K +, Cl-, Hb, Hct values should not be within the normal reference range,&#xD;
&#xD;
          -  Being a contraindication case for head and body positioning,&#xD;
&#xD;
          -  Not to volunteer to participate in the research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zonguldak Bülent Ecevit University Faculty of Health Sciences</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zonguldak Bülent Ecevit University Faculty of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zonguldak Bülent Ecevit University Health Practice and Research Hospital</name>
      <address>
        <city>Zonguldak</city>
        <state>Kozlu</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zonguldak Atatürk State Hospital</name>
      <address>
        <city>Zonguldak</city>
        <state>Meşrutiyet</state>
        <zip>67100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>March 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zonguldak Bulent Ecevit University</investigator_affiliation>
    <investigator_full_name>Sibel Köstekli</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>neurosurgery patient</keyword>
  <keyword>endotracheal suctioning</keyword>
  <keyword>nursing care</keyword>
  <keyword>cerebral oxygenation</keyword>
  <keyword>optimal head height</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data ready to be published as a result of the research will be shared.</ipd_description>
    <ipd_time_frame>It will be available once the research is complete and ready for publication. There is no limit for the date of access.</ipd_time_frame>
    <ipd_access_criteria>Completion and reporting of the study</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454931
org study id: 2019-19093093-01
nct id: NCT04454931
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In order for the brain, which is the most metabolically active organ of our body, to maintain
      its functions, it must reach oxygen saturation in the best way with continuous and rich blood
      flow.

      Neurosurgery patients are followed for a while in the intensive care unit with a mechanical
      ventilator. During the care of the patient in mechanical ventilation; position changes, head
      height, endotracheal aspiration, oral care and invasive procedures that cause painful stimuli
      to the patient are factors that can affect brain perfusion pressure and oxygenation status of
      brain cells. It is known that high intracranial pressure, especially during and after
      endotracheal aspiration application, causes serious conditions in patients by disrupting
      cerebral blood flow.

      It is also seen that cerebral blood flow is associated with head and body positions given in
      the postoperative period. It is stated in the literature that neurosurgical patients should
      be 30-45 degrees for proper head height in bed. In these patients, the height of the head
      should be in a suitable position for the correction of cerebral blood flow, which
      deteriorates during endotracheal aspiration, since autoregulation mechanisms are impaired or
      always activated. However, when the literature is examined, no information about the ideal
      head height that should be given to patients during endotracheal aspiration was found.

      In addition, one of the most important parameters indicating the presence of cerebral
      complications is monitoring of cerebral oxygenation. It is stated that the most appropriate
      follow-up for patients should be evaluated by nurses in a non-invasive method.

      In this study; In neurosurgery intensive care patients, endotracheal aspiration will be
      applied during endotracheal aspiration at head heights of 15, 30 and 45 degrees and it is
      aimed to determine the most appropriate head height during and after application by
      monitoring non-invasive cerebral oximeter device.
Although the brain is only 2% of body weight,it is the most metabolically active and vital
      organ of the body.Cells in the brain; they need higher amounts of oxygen and energy than
      other organs in the body. Therefore, in order to maintain brain functions,rich and continuous
      blood flow and optimal oxygen saturation are required. Cerebral blood flow(SKA) is the most
      important factor in nutrition that provides oxygen saturation. Cerebral blood flow;Cerebral
      perfusion pressure(SPB) is affected by mean arterial pressure(MAP) and intracranial
      pressure(KIB).Under normal conditions, while SPB is constant, the conditions affecting blood
      pressure and cerebral venous return and elevation of KIB affect SPB.While normal cerebral
      blood flow is 50-70 ml/100 g/tissue/min;In cases where blood flow is interrupted,serious flow
      disruptions occur in cerebral circulation when the flow rate drops below 20 ml and vital
      conditions such as cerebral ischemia occur.

      In cerebral blood flow intensive care patients;it may be disrupted during some maintenance
      procedures that cause painful stimuli such as position change,head height,endotracheal
      suctioning,oral care, and invasive procedures.In the literature;It is reported that if the
      cerebral blood flow drops below 20 ml/100 g/min for 30 minutes,it will reversibly stop the
      function of neurons,and if it falls below 10 ml/100 g/min for 30 minutes, irreversible neuron
      damage will occur.Therefore, in order to prevent unwanted cerebral ischemia in intensive care
      patients;Before each procedure applied to the patient, the amount of oxygen in the
      bloodstream circulating in the brain tissue should be constantly monitored. In the last guide
      published by the Brain Trauma Association;It is recommended that partial carbon dioxide
      pressure(PaCO2) is 35-40 mmHg, partial oxygen pressure(PaO2) is above 60 mmHg, and arterial
      oxygen saturation is 90% and above.In order to preserve these values, the patients are
      followed up in the mechanical ventilator for a while in the first period they exit the
      operation.

      While the fact that the patients are connected to the mechanical ventilator may provide
      advantage in terms of providing continuous oxygenation,it may bring additional risks for the
      patients. Because the endotracheal suctioning suctioning need arises in the patient in the
      mechanical ventilator.There are important risks of endotracheal suctioning of mechanically
      ventilated patients with artificial in patients receiving mechanical ventilator support to
      prevent hypercarbia and hypoxia caused by secretion accumulated in the respiratory
      tract.These risks include hypoxia, arrhythmia, increase in
      MPD,hypertension,hypotension,agitation,pain,etc. countable.Especially during endotracheal
      suctioning, the increase of intracranial pressure in the patient, then the cough reflex
      induced and the high course of intracranial pressure after suctioning will disrupt cerebral
      perfusion,thus oxygenation of the brain is endangered.While blood flow and perfusion may be
      normal before and during the procedure,it changes to critical value afterwards and if it
      lasts more than 30 minutes,it poses a threat to patients.The position of the patient and the
      length of stay in the same position affect the cerebral circulation,reducing SPB.In this
      case,if the nursing follow-ups are insufficient or the attempts to protect the SME are
      ineffective;it becomes difficult for the brain to perform its functions, and even becomes
      unable to perform.

      In the intensive care units,raising the head and positioning is a routine nursing initiative
      in order to protect patients from KIB and cerebral complications that may occur due to
      KIB.Different head heights and body positions applied after the neurosurgical intervention
      have been observed to affect secondary complications by affecting SME, PB and SKA.According
      to researches; lateral position given by raising the head of the bed, long-term flexion and
      extension of the head, the head being constantly 45° high are positions that may be harmful
      for neurosurgical patients.In addition, it has been reported that rotating or repositioning
      causes more secondary brain damage(7%) by increasing the ICU compared to other nursing
      interventions applied to patients. Secondary brain damage may result from 5 minutes after
      nursing interventions or more than 10 minutes from the beginning of nursing intervention,20
      mmHg above KIB,60 mmHg below SPB,and 100 mmHg below systolic blood pressure. Responsibility
      of neurosurgical nurses;It is the safest way to provide the care that the patient needs
      without experiencing any undesirable side effects and secondary complications (respiratory
      events,cerebral ischemia,increased ICP,arrhythmia, etc.).This is directly related to the
      quality of the treatments. The results of the research showed that nurses should follow the
      cerebral oxygenation with non-invasive technique by constantly moving away from the invasive
      methods that cause many complications such as infection,arrhythmia,vascular injury to
      patients in the neurosurgery intensive care unit.

      Since the oxygenation status of intensive care patients is measured and monitored with a
      pulse oximeter,the hypoxia state occurring in oxygenation in the brain tissue cannot be
      detected early. Standard methods used in the measurement of cerebral oxygenation have
      significant limitations in these patients.Jugular venous bulb oximetry measurement is an
      expensive method that requires invasive procedure;there is a risk of many complications such
      as infection on the patient, risk of tissue integrity deterioration,vascular injuries during
      bleeding of the catheter,bleeding; assessment of the measurement is essential by
      neurosurgeons;In addition, this method may miss regional ischemia.Non-invasive techniques
      such as transcranial doppler ultrasonography or electroencephalography(EEG) are other methods
      used indirectly to assess the adequacy of cerebral blood flow or the presence of
      ischemia.However,transcranial doppler and EEG are difficult to interpret by non-specialists.
      Cerebral oximetry device that measures oxygenation of the brain;It is important because it is
      a non-invasive method that monitors changes in cerebral oxygen metabolism,can provide
      continuous at the bedside, provides accurate and precise results as well as invasive
      methods,can provide nurses the convenience of interpretation independently in order not to
      cause secondary complications in nursing applications.Therefore,it can be easily evaluated in
      terms of nurses who are able to provide reliable and real-time data from several areas of the
      brain simultaneously, which is effective for the prevention and early detection of secondary
      injuries such as re-bleeding, vasospasm,cerebral ischemia,cerebral edema and seizure,and for
      24 hours of patients.Cerebral oximetry device that works with near infrared
      spectroscopy(NIRS) technology,which can be used as a bedside monitor, is considered to be the
      most suitable device for patients and healthcare workers.

      Studies have argued that low values in cerebral oximetry follow-ups may be predictors of
      hypoxic ischemic damage.In feasibility studies for the use of NIRS technology of
      neurocognitive and neurological complications during and after cardiac surgery;According to
      the transcranial doppler device of the cerebral oximeter device in adult patients;The use of
      this device has been suggested due to its advantages such as easy and uncomplicated
      use,clear,undoubtedly identifiable brain oxygenation, and nurses can evaluate
      independently.In studies, low regional regional oxygen level(rSO2) was directly and
      significantly interpreted with poor results after brain injury. In one study, the measurement
      of cerebral oxygen and hemoglobin values after vasospasm after subarachnoid hemorrhage was
      done with transcranial doppler and NIRS and its correlation with cortical ischemia was
      examined. Transcranial doppler failed to detect vasospasm in four of the six cases, while
      NIRS detected changes in the brain cortex and basal vessels.In the study,it was reported that
      a decrease of 3.9-6.4% compared to the basal value occurring in regional oxygenation was
      cut-off values predicting high sensitivity(100%) and specificity(85.7%) vasospasm.

      When the literature is examined; Evidence that cerebral oxygenation monitoring is important
      in preventing complications such as delayed cerebral ischemia is clear. However, there is no
      evidence of the head height to be given during endotracheal suctioning and how long the head
      should remain in this position by affecting cerebral blood flow and KIB,which plays an
      important role in oxygenation of the brain.In a study,it is desired that the head height of
      neurosurgery patients should be 30 ° in terms of cerebral perfusion and should not exceed the
      45 degree angle. Ledwith et al. (2010) also reported that the head height of 30 degrees in
      the supine position decreases CRB. Coşkun et al. (2011), in patients with cerebral vascular
      disease who did not undergo surgical intervention, they observed tracheal suctioning with a
      head height of only 15 and 30 degrees, and an increase in cerebral blood flow with a head
      height of 15 degrees in the measurement performed with transcranial doppler 5 minutes after
      the applicationWhen the intracranial pressure is continuously high for more than 30 minutes,
      SPB will deteriorate and the cerebral flow will be interrupted.In randomized controlled
      studies,it has been reported that adequate cerebral perfusion is provided at head heights up
      to 15 degrees and 60 degrees, but the ideal head height specified as 15° and 60° is very it
      remained uncertain in a wide range. In the results of the meta-analysis study, it was
      reported that the most suitable head height in terms of serabral perfusion was 30 and 45
      degrees from 0,15,30 and 45 degrees in patients who underwent neurosurgery. However,it has
      been emphasized that the results related to the ideal head height are still contradictory in
      situations related to position change and other applications. In one study, when the head
      height was reduced from 30 degrees to 0 degrees in patients with head injuries, when the
      cerebral perfusion change was measured with NIRS technology; Cerebral perfusion pressure
      showed a significant change during the reduction of head height (p <0.001) and it was
      observed that the level of cerebral perfusion and oxy-hemoglobin increased by decreasing the
      head height. Although medical and nursing studies on this subject are still continuing today,
      there is no study investigating the effect of the ideal head height that should be within 30
      minutes required for stabilization of cerebral perfusion and oxygenation during and after
      endotracheal suctioning.

      There are no studies on the use of NIRS technology in nursing applications for neurosurgical
      patients. Brogan et al. (2017) 's systematic review and metaanalysis study; It was emphasized
      that studies examining the benefits of this technology in patients with traumatic brain
      injury are insufficient, and that both doctors and nurses should prove the benefits of this
      technology before and inside the hospital by conducting experimental research. In a study in
      which cost analysis was performed in patients who were followed up using NIRS technology;It
      was determined that there was an average decrease of 1937 dollars per patient (p=0.036) and
      it was pointed out that NIRS is a sensitive and reliable monitoring tool that eliminates the
      need for special nursing care. In line with these results,it is predicted that the nurses who
      are with the patient for 24 hours and who participate in the care and treatment of the
      patient can provide significant benefits for the patient by using this technology.With the
      simple use of this technology by nurses in intensive care settings, it is aimed to prevent
      many problems that may occur in patients and it is also thought that it will be
      cost-effective in patients with long hospital stay.
observational model: Cohort
time perspective: Prospective
measure: To monitor the change of endotracheal suctioning in cerebral oxygenation parameter with non-invasive monitor in neurosurgery intensive care patients and to look at the statistical significance of the change.
time frame: The measurement will start with recording the value before the endotracheal suctıonıng application and end with recording the value at 30 minutes after the application. Results will be determined after reporting at the end of 1 year.
description: Preservation of neurosurgical patients' cerebral perfusion is very important for the prognosis of patients. It is known that endotracheal aspiration,which is one of the nursing care practices applied in the intensive care follow-up of these patients,impairs the cerebral perfusions.However, although it is known, it is not sufficient to monitor the parameters showing the srebral perfusion status by the nurses who are constantly present with the patient.This parameter will be monitored with the regional oximeter device,which is considered to be the most accurate and appropriate method during and after endotracheal aspiration,which is one of the applications that change the cerebral perfusion status the most.In the literature, follow-up up to 30 minutes was planned, as the time required to correct cerebral perfusion was reported as 30 minutes in these patients
measure: To look at the effect of using technology for early diagnosis of complications such as cerebral ischemia in neurosurgery intensive care patients.
time frame: 1 year
description: Changes in cerebral oxygenation may be an early sign of delayed complication of cerebral ischemia. Therefore, it is important to monitor the change in cerebral oxygenation. However, it is important that the best approach for monitoring this parameter is that patients can be monitored and evaluated by non-invasive healthcare professionals nurses, who are uninterrupted with the patients without leaving the intensive care environment. Therefore, the widespread use of such devices, which have proven their validity and reliability by using technology, suggests that the prognosis of the patients will have a good effect. Clinical research is needed for this. For this reason, in this group, which is a risky group, it is necessary to benefit from the technologies that non-invasive methods can be used without moving patients from their beds.
measure: To determine the effect of endotracheal aspiration on 15% head height in cerebral oxygenation in neurosurgery intensive care patients.
time frame: 1 year
description: Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 15 degrees of head height. Therefore, this is one of the results of this research.
measure: To determine the effect of endotracheal aspiration procedure applied at 30 degree head height on the percentage of cerebral oxygenation in neurosurgery intensive care patients.
time frame: 1 year
description: Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 30 degrees of head height. Therefore, this is one of the results of this research.
measure: To determine the effect of endotracheal aspiration on 45% head height in cerebral oxygenation in neurosurgery intensive care patients.
time frame: 1 year
description: Endotracheal aspiration application applied to patients disrupts the cerebral perfusion of patients. However, the impaired cerebral perfusion is expected to stabilize after application. If the time it takes for perfusion to return to normal exceeds 30 minutes, neuron damage begins to occur. During this period, the percentage of cerebral oxygenation, which is the parameter that shows the status of cerebral perfusion, should be monitored and necessary nursing care procedures should be carried out in order to stabilize. One application is to keep the head height of the patients at an appropriate angle. The ideal head height for this subject, which is a controversial subject in the literature and which is not yet talked about as evidence, is unknown. Clinical research is needed to examine the effect of 45 degrees of head height. Therefore, this is one of the results of this research.
measure: The effect of age,gender,diagnosis, number of hospitalization days,mechanical ventilatory mode, glaskow coma scale score variables on patients' cerebral oxygenation before and after endotracheal suctionıng in patients with mechanical ventilation
time frame: 1 year
description: Personal characteristics of the harvests related to the sociodemographic health status affect the general condition of the patients. The effect of endotracheal aspiration procedure applied to patients on cerebral oxygenation varies depending on these variables. Examining the direction of this effect is among the results of the research.
arm group label: Intensive care patients who underwent neurosurgery
description: Cerebral oxygenation status will be monitored during and after endotracheal suctioning in each patient included in the study. Non-invasive regional oximetry probes are placed in the frontal region of the patient and the patient will be positioned at the head height of 15 degrees with a 3-motor angle determining bearing system. Then, when the patient's need for endotracheal suctioning arises, endotracheal suctioning will be performed and the cerebral oxygenation status before the procedure, 1 minute, 5 minutes and 30 minutes after the procedure will be recorded on the monitor of the non-invasive regional oximeter device operating with NIRS technology. The same procedure will be applied to the patient at head heights of 30 and 45 degrees. Cerebral oxygenation status measured at each head height will be compared with appropriate statistical methods and the most appropriate head height will be determined.
intervention type: Device
intervention name: Root® with O3® Regional Oximetry
description: May help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.
It was aimed to determine the appropriate head height that should be given to patients in order to correct the endotracheal suctioning sequence, which is the most important care application of the neurosurgery patients who are followed up in the intensive care unit after surgery, and the possibility of subsequent disruption of cerebral perfusion. Therefore, cerebral oxygenation status, which is the most important parameter that shows the cerebral perfusion status of patients during and after the application, will be followed up by nurses with a non-invasive cerebral oximeter device.
arm group label: Intensive care patients who underwent neurosurgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zonguldak Bülent Ecevit University Faculty of Health Sciences
role: Principal Investigator
affiliation: Zonguldak Bülent Ecevit University Faculty of Health Sciences
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Zonguldak Bulent Ecevit University
investigator full name: Sibel Köstekli
investigator title: Research Assistant
sharing ipd: Yes
ipd description: All data ready to be published as a result of the research will be shared.
ipd time frame: It will be available once the research is complete and ready for publication. There is no limit for the date of access.
ipd access criteria: Completion and reporting of the study