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

NCT ID: NCT04454294

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-28

Study Completion Date

2019-12-12

Brief Summary

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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

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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.

Conditions

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Infant ALL Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Experimental Group (Absorption Group)

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Experimental Group (Milking Group)

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Kan Onturk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra Kan Öntürk, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

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Acıbadem University

Istanbul, Atasehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19740284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28457690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29076204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17962505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18414310 (View on PubMed)

Other Identifiers

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ATADEK 2018/11

Identifier Type: -

Identifier Source: org_study_id

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