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

A

Acibadem University

Status

Completed

Conditions

Infant ALL
Congenital Heart Disease

Treatments

Other: Control
Other: Experimental Group (Absorption Group)
Other: Experimental Group (Milking Group)

Study type

Interventional

Funder types

Other

Identifiers

NCT04454294
ATADEK 2018/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

1 to 12 months old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Control
Experimental group
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.
Treatment:
Other: Control
Experimental Group (Absorption Group)
Experimental group
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.
Treatment:
Other: Experimental Group (Absorption Group)
Experimental Group (Milking Group)
Experimental group
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.
Treatment:
Other: Experimental Group (Milking Group)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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