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

Not Applicable

Completed

• Conditions: Infant ALL; Congenital Heart Disease
• Interventions: Other: Control; Other: Experimental Group (Absorption Group); Other: Experimental Group (Milking Group)

• Registration Number: NCT04454294
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-07-28
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Experimental Group (Absorption Group)	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.
Experimental Group (Milking Group)	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.

Primary Outcome Measures

Name	Time	Method
Body temperature	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
Heart rate	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
Oxygen saturation	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
Respiratory rate	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
Blood pressure	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
Bleeding amount	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

Trial Locations

Locations (1)

Acıbadem University; 🇹🇷 Istanbul, Atasehir, Turkey