Clinical trial NCT04454294: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infant ALL
Congenital Heart Disease
Keywords: infant
congenital heart disease
drain patency
nursing
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Body temperature
timeFrame: 6 hours after surgery
measure: Heart rate
timeFrame: 6 hours after surgery
measure: Respiratory rate
timeFrame: 6 hours after surgery
measure: Blood pressure
timeFrame: 6 hours after surgery
measure: Oxygen saturation
timeFrame: 6 hours after surgery
measure: Bleeding amount
timeFrame: 6 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University
state: Atasehir
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.