xml: <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/NCT06020638</url>
    </required_header>
    <id_info>
      <org_study_id>2020/0072</org_study_id>
      <nct_id>NCT06020638</nct_id>
    </id_info>
    <brief_title>Determining The Effects Of Nasopharyngeal Suction</brief_title>
    <official_title>Determining The Effects Of Nasopharyngeal Suction With Negative And Positive Pressure: Randomised Conrolled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fenerbahce University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fenerbahce 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objective: The aim of the study is to determine the effects of nasopharyngeal suction with&#xD;
        negative and positive pressure on the pain level, respiratory parameters, and mucosal&#xD;
        irritation in infants.&#xD;
  &#xD;
        Materials and Methods: This study was conducted as a posttest randomised controlled&#xD;
        experimental research. The data were collected at XX Training and Research Hospital between&#xD;
        January and November 2020. While the positive pressure suction method was applied to the&#xD;
        experimental group, the negative pressure suction method was applied to the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nurses are responsible for suction function to clear the airway from secretions for effective&#xD;
        breathing. Suction is defined as the removal of secretions of the respiratory system with a&#xD;
        negative pressure vacuum device. In patients who are unable to extract respiratory secretions&#xD;
        independently, suction is essential to maintain the oxygen demand and ventilation at the&#xD;
        desired level and remove these secretions.&#xD;
  &#xD;
        The infant's respiratory and circulatory systems may be adversely affected as a result of the&#xD;
        suction procedure, and several complications such as trauma, haemorrhage, and pain may&#xD;
        develop. Suction is therefore one of the procedures that should be applied with caution in&#xD;
        infants. Suction procedures for the respiratory tract in infants include oro/nasopharyngeal&#xD;
        and endotracheal suction and suction methods include open and closed system suction methods.&#xD;
  &#xD;
        Oro/nasopharyngeal suction is a method that requires the use of negative pressure to remove&#xD;
        secretions from the oropharynx, nasopharynx, or both. When a foreign body penetrates the&#xD;
        trachea from the pharynx, when respiratory secretions are too much, or when the secretion&#xD;
        cannot be removed by normal cilia movement, coughing holds an important role. Inability to&#xD;
        cough leads to atelectasis, pneumonia, and respiratory failure during infection of the&#xD;
        respiratory tract. The cough reflex matures around the age of five in children. Adults are&#xD;
        able to quickly remove existing airway secretions, but children with excessive airway&#xD;
        secretions prior to this age are unable to do so easily. These secretions may be removed&#xD;
        through either nasopharyngeal or oropharyngeal suction.&#xD;
  &#xD;
        There are several risks and complications associated with suction procedure. The most common&#xD;
        are hypoxia, bradycardia, tachycardia, hypotension, hypertension, cardiac arrhythmia, cardiac&#xD;
        arrest, atelectasis, bronchospasm, elevated intracranial pressure, nosocomial infection,&#xD;
        tracheobronchial damage, and pain. Hypoxemia is the most prevalent and serious complication&#xD;
        among them. To avoid the suction-induced hypoxemia, different suction methods are being&#xD;
        developed and novel devices are being employed.Suction, a painful procedure, has been&#xD;
        reported to negatively impact the physiological parameters, comfort, sleep, growth, and&#xD;
        hospital stay of infants. The primary goal of pain management in infants is to minimise the&#xD;
        pain experienced by infants due to various medical procedures and allow them to cope with the&#xD;
        pain.&#xD;
  &#xD;
        When the literature was reviewed, it was observed that the respiratory rate, heart rate, SpO2&#xD;
        and tidal volumes of the patients were assessed as respiratory parameters, while spirometry&#xD;
        was utilized to assess respiratory function.&#xD;
  &#xD;
        Trauma is another complication of negative pressure suction. Suctioning of the tracheal,&#xD;
        oral, and nasopharyngeal mucosa caused by negative pressure may result in haemorrhage and&#xD;
        ulceration. As a result of the increased vacuum pressure generated during suction, the&#xD;
        mucosal fragments are displaced from the catheter holes and absorbed.&#xD;
  &#xD;
        Objective This study aimed to determine the effects of nasopharyngeal suction with negative&#xD;
        and positive pressure on the level of pain, respiratory parameters, and mucosal irritation in&#xD;
        infants.&#xD;
  &#xD;
        Research Hypotheses H0: There is no difference between positive pressure nasopharyngeal&#xD;
        aspiration procedure and negative pressure nasopharyngeal aspiration procedure.&#xD;
  &#xD;
        H1: The level of pain felt by infants during nasopharyngeal suction with positive pressure is&#xD;
        lower than the level of pain they suffer during nasopharyngeal suction with negative&#xD;
        pressure.&#xD;
  &#xD;
        H2: In infants, the SpO2 level after nasopharyngeal suction with positive pressure is higher&#xD;
        than the SpO2 level following nasopharyngeal suction with negative pressure.&#xD;
  &#xD;
        H3: In infants, the respiratory rate after nasopharyngeal suction with positive pressure is&#xD;
        less affected than the respiratory rate following nasopharyngeal suction with negative&#xD;
        pressure.&#xD;
  &#xD;
        H4: In infants, the mucosal irritation caused by the nasopharyngeal suction with positive&#xD;
        pressure is less than the mucosal irritation caused by the nasopharyngeal suction with&#xD;
        negative pressure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2023</start_date>
    <completion_date type="Actual">May 12, 2023</completion_date>
    <primary_completion_date type="Actual">March 11, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>This study was designed as randomized, controlled, and experimental</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain</measure>
      <time_frame>Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure</time_frame>
      <description>Determining the pain level with the Wong-Baker Faces Pain Rating Scale. Wong-Baker FACES Pain Rating Scale (Wong &amp; Baker, 1988) is an adaptation of the &quot;Faces Rating Scale&quot; which is a picture projection technique for assessing child pain and utilizes 6 illustrations of faces that a child in pain uses to best describe their present level of pain.&#xD;
  Face 0 depicts a happy face with no pain. Face 5 depicts a crying face that &quot;hurts as much as you can imagine, although you don't have to be crying to feel this bad.&quot; Responses on the 5-point scale range from 0 (very happy, no hurt) to 5 (hurts as much as you can imagine).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory Parameters</measure>
      <time_frame>Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure</time_frame>
      <description>Determining The Effect of Suction on SpO2 level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mucosal İrritation</measure>
      <time_frame>Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure</time_frame>
      <description>Determining The Existence of Mucosal İrritation (bleeding or absent)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Aspiration, Respiratory</condition>
    <condition>Pain</condition>
    <condition>Mucosal Irritation</condition>
    <condition>Infant</condition>
    <arm_group>
      <arm_group_label>Experimental group (Positive Pressure Group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, to the nostril on the other side 1-2 ml of physiological saline (PS- Mustela trademark), is injected with a 2,5-milliliter syringe (Can Medikal trademark), and then positive pressure is exerted with the help of the end of the oxygen connection hose (CGR Medikal trademark) from the same nostril, with oxygen or air supply at 5-8 lt/min (liter/minute) (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which physiological saline (PS) has been not injected. The oxygen connection hose is held one centimeter away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (Negative Pressure Group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS- Mustela trademark) like experimental group, and then negative pressure suction was performed using a pine-tipped suction set (Bıcakcılar trademark). The suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Experimental group</intervention_name>
      <description>THE EFFECTS OF NASOPHARYNGEAL SUCTION POSITIVE PRESSURE</description>
      <arm_group_label>Experimental group (Positive Pressure Group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>control group</intervention_name>
      <description>THE EFFECTS OF NASOPHARYNGEAL SUCTION NEGATIVE PRESSURE</description>
      <arm_group_label>Control group (Negative Pressure Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Existence of secretion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being premature&#xD;
  &#xD;
            -  without family consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>37 Weeks</minimum_age>
      <maximum_age>40 Weeks</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>kokkiz</last_name>
      <role>Study Director</role>
      <affiliation>Fenerbahce University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medeniyet University Goztepe Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Kadiköy</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fenerbahce University</investigator_affiliation>
      <investigator_full_name>Rukiye Kokkiz</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020638
  org study id: 2020/0072
  nct id: NCT06020638
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: The aim of the study is to determine the effects of nasopharyngeal suction with
        negative and positive pressure on the pain level, respiratory parameters, and mucosal
        irritation in infants.
  
        Materials and Methods: This study was conducted as a posttest randomised controlled
        experimental research. The data were collected at XX Training and Research Hospital between
        January and November 2020. While the positive pressure suction method was applied to the
        experimental group, the negative pressure suction method was applied to the control group.
  Nurses are responsible for suction function to clear the airway from secretions for effective
        breathing. Suction is defined as the removal of secretions of the respiratory system with a
        negative pressure vacuum device. In patients who are unable to extract respiratory secretions
        independently, suction is essential to maintain the oxygen demand and ventilation at the
        desired level and remove these secretions.
  
        The infant's respiratory and circulatory systems may be adversely affected as a result of the
        suction procedure, and several complications such as trauma, haemorrhage, and pain may
        develop. Suction is therefore one of the procedures that should be applied with caution in
        infants. Suction procedures for the respiratory tract in infants include oro/nasopharyngeal
        and endotracheal suction and suction methods include open and closed system suction methods.
  
        Oro/nasopharyngeal suction is a method that requires the use of negative pressure to remove
        secretions from the oropharynx, nasopharynx, or both. When a foreign body penetrates the
        trachea from the pharynx, when respiratory secretions are too much, or when the secretion
        cannot be removed by normal cilia movement, coughing holds an important role. Inability to
        cough leads to atelectasis, pneumonia, and respiratory failure during infection of the
        respiratory tract. The cough reflex matures around the age of five in children. Adults are
        able to quickly remove existing airway secretions, but children with excessive airway
        secretions prior to this age are unable to do so easily. These secretions may be removed
        through either nasopharyngeal or oropharyngeal suction.
  
        There are several risks and complications associated with suction procedure. The most common
        are hypoxia, bradycardia, tachycardia, hypotension, hypertension, cardiac arrhythmia, cardiac
        arrest, atelectasis, bronchospasm, elevated intracranial pressure, nosocomial infection,
        tracheobronchial damage, and pain. Hypoxemia is the most prevalent and serious complication
        among them. To avoid the suction-induced hypoxemia, different suction methods are being
        developed and novel devices are being employed.Suction, a painful procedure, has been
        reported to negatively impact the physiological parameters, comfort, sleep, growth, and
        hospital stay of infants. The primary goal of pain management in infants is to minimise the
        pain experienced by infants due to various medical procedures and allow them to cope with the
        pain.
  
        When the literature was reviewed, it was observed that the respiratory rate, heart rate, SpO2
        and tidal volumes of the patients were assessed as respiratory parameters, while spirometry
        was utilized to assess respiratory function.
  
        Trauma is another complication of negative pressure suction. Suctioning of the tracheal,
        oral, and nasopharyngeal mucosa caused by negative pressure may result in haemorrhage and
        ulceration. As a result of the increased vacuum pressure generated during suction, the
        mucosal fragments are displaced from the catheter holes and absorbed.
  
        Objective This study aimed to determine the effects of nasopharyngeal suction with negative
        and positive pressure on the level of pain, respiratory parameters, and mucosal irritation in
        infants.
  
        Research Hypotheses H0: There is no difference between positive pressure nasopharyngeal
        aspiration procedure and negative pressure nasopharyngeal aspiration procedure.
  
        H1: The level of pain felt by infants during nasopharyngeal suction with positive pressure is
        lower than the level of pain they suffer during nasopharyngeal suction with negative
        pressure.
  
        H2: In infants, the SpO2 level after nasopharyngeal suction with positive pressure is higher
        than the SpO2 level following nasopharyngeal suction with negative pressure.
  
        H3: In infants, the respiratory rate after nasopharyngeal suction with positive pressure is
        less affected than the respiratory rate following nasopharyngeal suction with negative
        pressure.
  
        H4: In infants, the mucosal irritation caused by the nasopharyngeal suction with positive
        pressure is less than the mucosal irritation caused by the nasopharyngeal suction with
        negative pressure.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This study was designed as randomized, controlled, and experimental
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Pain
  time frame: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
  description: Determining the pain level with the Wong-Baker Faces Pain Rating Scale. Wong-Baker FACES Pain Rating Scale (Wong & Baker, 1988) is an adaptation of the "Faces Rating Scale" which is a picture projection technique for assessing child pain and utilizes 6 illustrations of faces that a child in pain uses to best describe their present level of pain.
  Face 0 depicts a happy face with no pain. Face 5 depicts a crying face that "hurts as much as you can imagine, although you don't have to be crying to feel this bad." Responses on the 5-point scale range from 0 (very happy, no hurt) to 5 (hurts as much as you can imagine).
  measure: Respiratory Parameters
  time frame: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
  description: Determining The Effect of Suction on SpO2 level
  measure: Mucosal İrritation
  time frame: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
  description: Determining The Existence of Mucosal İrritation (bleeding or absent)
  arm group label: Experimental group (Positive Pressure Group)
  arm group type: Experimental
  description: The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, to the nostril on the other side 1-2 ml of physiological saline (PS- Mustela trademark), is injected with a 2,5-milliliter syringe (Can Medikal trademark), and then positive pressure is exerted with the help of the end of the oxygen connection hose (CGR Medikal trademark) from the same nostril, with oxygen or air supply at 5-8 lt/min (liter/minute) (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which physiological saline (PS) has been not injected. The oxygen connection hose is held one centimeter away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.
  arm group label: Control group (Negative Pressure Group)
  arm group type: Active Comparator
  description: The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS- Mustela trademark) like experimental group, and then negative pressure suction was performed using a pine-tipped suction set (Bıcakcılar trademark). The suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds
  intervention type: Device
  intervention name: Experimental group
  description: THE EFFECTS OF NASOPHARYNGEAL SUCTION POSITIVE PRESSURE
  arm group label: Experimental group (Positive Pressure Group)
  intervention type: Device
  intervention name: control group
  description: THE EFFECTS OF NASOPHARYNGEAL SUCTION NEGATIVE PRESSURE
  arm group label: Control group (Negative Pressure Group)
  criteria: 
  gender: All
  minimum age: 37 Weeks
  maximum age: 40 Weeks
  healthy volunteers: Accepts Healthy Volunteers
  last name: kokkiz
  role: Study Director
  affiliation: Fenerbahce University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Fenerbahce University
  investigator full name: Rukiye Kokkiz
  investigator title: Research Assistant
  mesh term: Respiratory Aspiration