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Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454294
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zehra Kan Onturk, Acibadem University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant ALL Congenital Heart Disease Other: Control Other: Experimental Group (Absorption Group) Other: Experimental Group (Milking Group) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control
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.
Other: Control

Common Process Steps:

  1. Informed consent forms will be signed by those who wish to take part in the research.
  2. The form in which individual characteristics are questioned will be filled.
  3. Hands will be washed, gloves will be worn.
  4. Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded.
  5. Drains will be kept parallel to the ground and upright.
  6. Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity.
  7. It will be ensured that all connections between the chest tubes and drainage unit are tight and secure.
  8. Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage.
  9. 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


Experimental: Experimental Group (Absorption Group)
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.
Other: Experimental Group (Absorption Group)
  1. Common process steps
  2. 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.
  3. Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room.
  4. Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20.
  5. The application will continue without interruption until the patient's drain need and the doctor's request is ended.
  6. During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.

Experimental: Experimental Group (Milking Group)
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.
Other: Experimental Group (Milking Group)
  1. Common process steps will be applied
  2. Operation will start from the area near the drain entrance point
  3. Latex tube will be folded into 12 cm long pieces and will be gripped with two hands
  4. The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand.
  5. This process will be repeated in the distal part.
  6. After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.




Primary Outcome Measures :
  1. Body temperature [ Time Frame: 6 hours after surgery ]
    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

  2. Heart rate [ Time Frame: 6 hours after surgery ]
    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

  3. Respiratory rate [ Time Frame: 6 hours after surgery ]
    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

  4. Blood pressure [ Time Frame: 6 hours after surgery ]
    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

  5. Oxygen saturation [ Time Frame: 6 hours after surgery ]
    This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery

  6. Bleeding amount [ Time Frame: 6 hours after surgery ]
    This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Parents / legal guardian agree to participate in the study and sign the informed consent form,

  • Having undergone congenital cardivascular surgery for the first time,
  • Chest and / or mediastinal drain after cardiac surgery,
  • Without secondary congenital anomaly and chronic disease,
  • No neurological symptoms,
  • No sepsis,
  • 1 month - 1 year old age group,
  • Anticoagulant use after surgery and during research,

Exclusion Criteria:

  • Receiving extra corporal membrane oxygenation support,

    • Sternum admitted to open intensive care,
    • Receiving intraaortic balloon pump support,
    • Reoperative
  • Complicated cases with bleeding diathesis and thought to be highly drained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454294


Contacts
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Contact: Zehra Kan Öntürk, Ass. Prof. +9002165004163 zehra.kan@acibadem.edu.tr
Contact: Zehra Kan Öntürk +9002165004163 zehra.kan@acibadem.edu.tr

Locations
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Turkey
Acıbadem University Recruiting
Istanbul, Atasehir, Turkey
Contact: Ükke Karabacak, Prof.         
Sponsors and Collaborators
Acibadem University
Investigators
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Principal Investigator: Zehra Kan Öntürk, Ass. Prof. Acibadem University
Publications:
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Responsible Party: Zehra Kan Onturk, Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier: NCT04454294    
Other Study ID Numbers: ATADEK 2018/11
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zehra Kan Onturk, Acibadem University:
infant
congenital heart disease
drain patency
nursing
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases