search
Back to results

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

Primary Purpose

Infant ALL, Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control
Experimental Group (Absorption Group)
Experimental Group (Milking Group)
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant ALL focused on measuring infant, congenital heart disease, drain patency, nursing

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acıbadem University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Experimental Group (Absorption Group)

Experimental Group (Milking Group)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Body temperature
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
Heart rate
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
Respiratory rate
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
Blood pressure
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
Oxygen saturation
This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Bleeding amount
This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery

Secondary Outcome Measures

Full Information

First Posted
June 25, 2020
Last Updated
August 25, 2021
Sponsor
Acibadem University
search

1. Study Identification

Unique Protocol Identification Number
NCT04454294
Brief Title
Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant ALL, Congenital Heart Disease
Keywords
infant, congenital heart disease, drain patency, nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm 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 Title
Experimental Group (Absorption Group)
Arm Type
Experimental
Arm 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 Title
Experimental Group (Milking Group)
Arm Type
Experimental
Arm 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(s)
Control
Intervention 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
Intervention Type
Other
Intervention Name(s)
Experimental Group (Absorption Group)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Experimental Group (Milking Group)
Intervention 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.
Primary Outcome Measure Information:
Title
Body temperature
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
Time Frame
6 hours after surgery
Title
Heart rate
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
Time Frame
6 hours after surgery
Title
Respiratory rate
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
Time Frame
6 hours after surgery
Title
Blood pressure
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
Time Frame
6 hours after surgery
Title
Oxygen saturation
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
Time Frame
6 hours after surgery
Title
Bleeding amount
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
Time Frame
6 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Ass. Prof.
Organizational Affiliation
Acibadem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem University
City
Istanbul
State/Province
Atasehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19740284
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.
Results Reference
background
PubMed Identifier
28457690
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.
Results Reference
background
PubMed Identifier
29076204
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.
Results Reference
background
PubMed Identifier
17962505
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.
Results Reference
background
PubMed Identifier
18414310
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs