<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/NCT04454294</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK 2018/11</org_study_id>
    <nct_id>NCT04454294</nct_id>
  </id_info>
  <brief_title>Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery</brief_title>
  <official_title>Determining the Effect of Two Different Methods on Bleeding, Vital Signs and Oxygen Saturation in Children to Maintain Drain Patency After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem 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>
      In this study, it was aimed to determine the effect of the use of milking and sucking methods&#xD;
      on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal&#xD;
      drains after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient admitted to the post-operative Cardiovascular Surgery Intensive Care Units&#xD;
      primarily meets two nurses and is responsible for the arrangement of medical equipment,&#xD;
      monitoring, monitoring, maintaining, recording, and performing the necessary treatments. Then&#xD;
      the nurse positions the drain after checking the drain connections, checks the level of the&#xD;
      drain and records it in the nurse follow-up note. Then, the method to be used in maintaining&#xD;
      the drain opening is decided in cooperation with the physician.&#xD;
&#xD;
      Three different methods are currently used in the unit. The first method; There is no&#xD;
      application in maintaining the drain opening, but if there are necessary medical indications&#xD;
      such as clot formation, blood accumulation in the drainage connections, lack of drainage,&#xD;
      this group is intervened by milking method. In our study, this group will be taken as a&#xD;
      control group, there will be a situation that requires intervention in the first 6 hours, and&#xD;
      if the milking method is used, it will be excluded from the sample.&#xD;
&#xD;
      The second method used to maintain the drain opening is the suction method. In this study,&#xD;
      this group will be taken as the first experimental group. The suction method is a continuous&#xD;
      use until the patient's drainage requirement and the physician's request is terminated by&#xD;
      ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the&#xD;
      appropriate negative pressure tracking system of the patient, who is accepted with intensive&#xD;
      care under water drainage system, is established. system.&#xD;
&#xD;
      The third method is milking. In our study, this group will be taken as the 2nd experimental&#xD;
      group. In the milking method, the process starts from the area close to the drain entry&#xD;
      point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse&#xD;
      repeats the process 3 times by compressing the parts gripped by the hand. This process is&#xD;
      then used at intervals every hour to repeat the distal part.&#xD;
&#xD;
      After the applications related to the method to be used are performed, the patient's vital&#xD;
      signs, Sp02 and bleeding amount are generally monitored every hour.&#xD;
&#xD;
      In this study, the data for each group will be collected before and after the procedure for 6&#xD;
      hours after surgery, from the moment the patient is admitted to the intensive care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2018</start_date>
  <completion_date type="Actual">December 12, 2019</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome contains both systolic and diastolic blood pressure. Blood pressure measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding amount</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Infant ALL</condition>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group (Absorption Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group (Milking Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Common Process Steps:&#xD;
Informed consent forms will be signed by those who wish to take part in the research.&#xD;
The form in which individual characteristics are questioned will be filled.&#xD;
Hands will be washed, gloves will be worn.&#xD;
Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded.&#xD;
Drains will be kept parallel to the ground and upright.&#xD;
Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity.&#xD;
It will be ensured that all connections between the chest tubes and drainage unit are tight and secure.&#xD;
Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage.&#xD;
To prevent the tubes from coming out, they will be fixed to the patient bed.&#xD;
Vital signs, Sp02 and bleeding amount will be recorded every hour for 6 hours after surgery</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Group (Absorption Group)</intervention_name>
    <description>Common process steps&#xD;
Appropriate negative pressure monitoring system of the patient, who is admitted to the intensive care unit with underwater drainage system, will be established.&#xD;
The suction control room combined with the vacuum regulator will be filled with sterile distilled water up to the specified level (20 cm H2O).&#xD;
From the vacuum regulator, the drain or drains will be connected tightly and by preventing the crimping, from the aspirator receptor hoses.&#xD;
Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room.&#xD;
Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20.&#xD;
The application will continue without interruption until the patient's drain need and the doctor's request is ended.&#xD;
During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.</description>
    <arm_group_label>Experimental Group (Absorption Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Group (Milking Group)</intervention_name>
    <description>Common process steps will be applied&#xD;
Operation will start from the area near the drain entrance point&#xD;
Latex tube will be folded into 12 cm long pieces and will be gripped with two hands&#xD;
The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand.&#xD;
This process will be repeated in the distal part.&#xD;
After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.</description>
    <arm_group_label>Experimental Group (Milking Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Parents / legal guardian agree to participate in the study and sign the informed consent&#xD;
        form,&#xD;
&#xD;
          -  Having undergone congenital cardivascular surgery for the first time,&#xD;
&#xD;
          -  Chest and / or mediastinal drain after cardiac surgery,&#xD;
&#xD;
          -  Without secondary congenital anomaly and chronic disease,&#xD;
&#xD;
          -  No neurological symptoms,&#xD;
&#xD;
          -  No sepsis,&#xD;
&#xD;
          -  1 month - 1 year old age group,&#xD;
&#xD;
          -  Anticoagulant use after surgery and during research,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving extra corporal membrane oxygenation support,&#xD;
&#xD;
               -  Sternum admitted to open intensive care,&#xD;
&#xD;
               -  Receiving intraaortic balloon pump support,&#xD;
&#xD;
               -  Reoperative&#xD;
&#xD;
          -  Complicated cases with bleeding diathesis and thought to be highly drained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zehra Kan Öntürk, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Acibadem University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Acıbadem University</name>
      <address>
        <city>Istanbul</city>
        <state>Atasehir</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.</citation>
    <PMID>19740284</PMID>
  </reference>
  <reference>
    <citation>Cook M, Idzior L, Bena JF, Albert NM. Nurse and patient factors that influence nursing time in chest tube management early after open heart surgery: A descriptive, correlational study. Intensive Crit Care Nurs. 2017 Oct;42:116-121. doi: 10.1016/j.iccn.2017.03.008. Epub 2017 Apr 28.</citation>
    <PMID>28457690</PMID>
  </reference>
  <reference>
    <citation>Lu C, Jin YH, Gao W, Shi YX, Xia X, Sun WX, Tang Q, Wang Y, Li G, Si J. Variation in nurse self-reported practice of managing chest tubes: A cross-sectional study. J Clin Nurs. 2018 Mar;27(5-6):e1013-e1021. doi: 10.1111/jocn.14127. Epub 2018 Feb 21.</citation>
    <PMID>29076204</PMID>
  </reference>
  <reference>
    <citation>Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. No abstract available. Erratum In: Am J Crit Care. 2008 May;17(3):193.</citation>
    <PMID>17962505</PMID>
  </reference>
  <reference>
    <citation>Sullivan B. Nursing management of patients with a chest drain. Br J Nurs. 2008 Mar 27-Apr 9;17(6):388-93. doi: 10.12968/bjon.2008.17.6.28906.</citation>
    <PMID>18414310</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Zehra Kan Onturk</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>infant</keyword>
  <keyword>congenital heart disease</keyword>
  <keyword>drain patency</keyword>
  <keyword>nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04454294
org study id: ATADEK 2018/11
nct id: NCT04454294
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, it was aimed to determine the effect of the use of milking and sucking methods
      on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal
      drains after cardiac surgery.
The patient admitted to the post-operative Cardiovascular Surgery Intensive Care Units
      primarily meets two nurses and is responsible for the arrangement of medical equipment,
      monitoring, monitoring, maintaining, recording, and performing the necessary treatments. Then
      the nurse positions the drain after checking the drain connections, checks the level of the
      drain and records it in the nurse follow-up note. Then, the method to be used in maintaining
      the drain opening is decided in cooperation with the physician.

      Three different methods are currently used in the unit. The first method; There is no
      application in maintaining the drain opening, but if there are necessary medical indications
      such as clot formation, blood accumulation in the drainage connections, lack of drainage,
      this group is intervened by milking method. In our study, this group will be taken as a
      control group, there will be a situation that requires intervention in the first 6 hours, and
      if the milking method is used, it will be excluded from the sample.

      The second method used to maintain the drain opening is the suction method. In this study,
      this group will be taken as the first experimental group. The suction method is a continuous
      use until the patient's drainage requirement and the physician's request is terminated by
      ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the
      appropriate negative pressure tracking system of the patient, who is accepted with intensive
      care under water drainage system, is established. system.

      The third method is milking. In our study, this group will be taken as the 2nd experimental
      group. In the milking method, the process starts from the area close to the drain entry
      point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse
      repeats the process 3 times by compressing the parts gripped by the hand. This process is
      then used at intervals every hour to repeat the distal part.

      After the applications related to the method to be used are performed, the patient's vital
      signs, Sp02 and bleeding amount are generally monitored every hour.

      In this study, the data for each group will be collected before and after the procedure for 6
      hours after surgery, from the moment the patient is admitted to the intensive care unit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Body temperature
time frame: 6 hours after surgery
description: This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary. The data for each group will be collected before and after the procedure for 6 hours after surgery
measure: Heart rate
time frame: 6 hours after surgery
description: This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
measure: Respiratory rate
time frame: 6 hours after surgery
description: This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
measure: Blood pressure
time frame: 6 hours after surgery
description: This outcome contains both systolic and diastolic blood pressure. Blood pressure measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
measure: Oxygen saturation
time frame: 6 hours after surgery
description: This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
measure: Bleeding amount
time frame: 6 hours after surgery
description: This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery
arm group label: Control
arm group type: Experimental
description: The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample.
arm group label: Experimental Group (Absorption Group)
arm group type: Experimental
description: The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system.
arm group label: Experimental Group (Milking Group)
arm group type: Experimental
description: The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part.
intervention type: Other
intervention name: Control
description: Common Process Steps:
Informed consent forms will be signed by those who wish to take part in the research.
The form in which individual characteristics are questioned will be filled.
Hands will be washed, gloves will be worn.
Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded.
Drains will be kept parallel to the ground and upright.
Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity.
It will be ensured that all connections between the chest tubes and drainage unit are tight and secure.
Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage.
To prevent the tubes from coming out, they will be fixed to the patient bed.
Vital signs, Sp02 and bleeding amount will be recorded every hour for 6 hours after surgery
arm group label: Control
intervention type: Other
intervention name: Experimental Group (Absorption Group)
description: Common process steps
Appropriate negative pressure monitoring system of the patient, who is admitted to the intensive care unit with underwater drainage system, will be established.
The suction control room combined with the vacuum regulator will be filled with sterile distilled water up to the specified level (20 cm H2O).
From the vacuum regulator, the drain or drains will be connected tightly and by preventing the crimping, from the aspirator receptor hoses.
Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room.
Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20.
The application will continue without interruption until the patient's drain need and the doctor's request is ended.
During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.
arm group label: Experimental Group (Absorption Group)
intervention type: Other
intervention name: Experimental Group (Milking Group)
description: Common process steps will be applied
Operation will start from the area near the drain entrance point
Latex tube will be folded into 12 cm long pieces and will be gripped with two hands
The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand.
This process will be repeated in the distal part.
After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.
arm group label: Experimental Group (Milking Group)
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Months
healthy volunteers: No
last name: Zehra Kan Öntürk, Ass. Prof.
role: Principal Investigator
affiliation: Acibadem University
facility: 
country: Turkey
citation: Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.
PMID: 19740284
citation: Cook M, Idzior L, Bena JF, Albert NM. Nurse and patient factors that influence nursing time in chest tube management early after open heart surgery: A descriptive, correlational study. Intensive Crit Care Nurs. 2017 Oct;42:116-121. doi: 10.1016/j.iccn.2017.03.008. Epub 2017 Apr 28.
PMID: 28457690
citation: Lu C, Jin YH, Gao W, Shi YX, Xia X, Sun WX, Tang Q, Wang Y, Li G, Si J. Variation in nurse self-reported practice of managing chest tubes: A cross-sectional study. J Clin Nurs. 2018 Mar;27(5-6):e1013-e1021. doi: 10.1111/jocn.14127. Epub 2018 Feb 21.
PMID: 29076204
citation: Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. No abstract available. Erratum In: Am J Crit Care. 2008 May;17(3):193.
PMID: 17962505
citation: Sullivan B. Nursing management of patients with a chest drain. Br J Nurs. 2008 Mar 27-Apr 9;17(6):388-93. doi: 10.12968/bjon.2008.17.6.28906.
PMID: 18414310
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Zehra Kan Onturk
investigator title: Assistant Professor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No