Clinical trial NCT05393128: The Effect of Different Positions in Children After Cardiac Surgery
Official title: The Effect of Different Positions in Children After Cardiac Surgery On Vital Signs And Oxygen Saturation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant ALL
Keywords: pediatric heart surgery
position
infant
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery.

Detailed description: Convenient ventilation management after pediatric cardiac surgery and the positioning of the patient helps to reduce the maximum intrathoracic pressure and venous stasis of the trunk and upper extremities that facilitates the drainage of the blood in the lungs. Due to the fact that the Pre-operative and post-operative management has tremendously changed for the last years, more detailed and up-to-date information is required related to the effect of the body position on the changes of the lung capacities and the pulmonary function. Based on this reason, this research was designed to determine the effect of three different positions as a randomized controlled prospective study.

In case the unit does not contain as routine any obstacle for position (unilateral oedema, ciculation disorder in the extremities, non-bilateral pulmonary atelectasis or dense infiltration, patients who cannot be administered dormicum or fentaver) right lateral, left lateral and supine positions are given. First positioning; also in routine, the standart position given to the first patients is supine position. The patient is first placed supine. Then his arms and legs are supported with support pillows. Transducer level and cuff pressure are controlled, SpO2 probe, ECG probes are controlled. If there's CVK connection, if there isn't any arterial connection, the cuff is controlled and in order to avoid heat loss the patient is covered after controling the body temperature and the position is completed.

In positioning, the 2nd method is right lateral positioning. In this positioning, the patient bed is straightened. Later on, the patient's SpO2 probe, ECG probes, CVK, arterial and cuff connections are once again moved to the right side of the patient and moved from below the patient's body without contact with the body in order to ensure the connections. Then, the patient is turned to right side with angle of 60 or 90 degrees and back is supported with a pillow from the neck to his sacrum, between the legs is also supported with a pillow. Afterwards, the patient's head is elevated with 45 to 60 degrees. Body temperature is controlled. The body is covered in order to avoid temperature loss and position is completed.

The third position that is used is left lateral position. In this positioning, the patient bed is straightened. Then, the patient's SpO2 probe, ECG probe, CVK, artery and cuff connections are transferred to the left side and the connections are made by passing the connections from below the pillow of the patient without touching the body. Later on, The patient is turned to left side with angle of 60 or 90 degrees to the left and the patient's back is supported with pillow from the neck until the sacrum, between the legs is again covered with a pillow. After that, the patient's head is elevated with 45-60 degrees. Body temperature is controlled, covered in order to avoid temperature loss and position is completed.

In this unit, after performing the applications related to the method used, the patient's vital signs and SpO2 are checked and recorded every half hour in the postoperative 24 hours, and hourly in the following processes.

In this study, implementation and data collection for each group will begin after the patient is admitted to the intensive care unit, after stabilization of the surgery (after the 12th hour). Until this time, the patient's follow-up is done in supine position. After stabilization, with the cooperation of the physician, it will continue to be supported by the right lateral and left lateral positions in addition to the supine position every 2 hours. Vital signs and SpO2 values of the patient will be recorded just before positioning, at the 1st minute, 1st hour and its 2nd hour after positioning.

Eligibility criteria: Inclusion Criteria:

* First time experiencing congenital cardiovascular surgery,
* Having Bilateral pulmonary atelectasis assessment,
* Not having any secondary congenital anomaly or chronic disease,
* Not having any neurologic symptoms,
* Being between 1 month - 1 year old
* Not having bilateral circulatory disorder and not having any obstacle to the position,
* Being Intubated
* Receiving 1 mg/kg dormicum, 0,1 mcg/kg fentaver infusion

Exclusion Criteria:

* Receiving Extra Corporal Membrane Exygenation support,
* Admitted to ICU with sternum exposed,
* Receiving Intraaortic balloon pump support,
* Being a Pre-op period patient,
* Having a non-bilateral circulatory disorder,
* Having unilateral thorax drain,
* Being extubated or being planned for extubation during the study period,
* Receiving Rocuranium,
* Not receiving Dormicum or fentaver

Primary outcomes:
measure: Change in Body Temperature
timeFrame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
measure: Change in Heart Rate
timeFrame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
measure: Change in Blood Pressure
timeFrame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
measure: Change in Respiratory Rate
timeFrame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
measure: Change in Oxygen Saturation
timeFrame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Education and Research Hospital
state: Kadıköy
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva ME, Feuser MR, Silva MP, Uhlig S, Parazzi PL, Rosa GJ, Schivinski CI. Pediatric cardiac surgery: what to expect from physiotherapeutic intervention? Rev Bras Cir Cardiovasc. 2011 Apr-Jun;26(2):264-72. doi: 10.1590/s0102-76382011000200018. English, Portuguese.
citation: Thomas PJ, Paratz JD. Is there evidence to support the use of lateral positioning in intensive care? A systematic review. Anaesth Intensive Care. 2007 Apr;35(2):239-55. doi: 10.1177/0310057X0703500214.
citation: de Laat E, Schoonhoven L, Grypdonck M, Verbeek A, de Graaf R, Pickkers P, van Achterberg T. Early postoperative 30 degrees lateral positioning after coronary artery surgery: influence on cardiac output. J Clin Nurs. 2007 Apr;16(4):654-61. doi: 10.1111/j.1365-2702.2006.01715.x.
citation: Hickey PA, Pasquali SK, Gaynor JW, He X, Hill KD, Connor JA, Gauvreau K, Jacobs ML, Jacobs JP, Hirsch-Romano JC. Critical Care Nursing's Impact on Pediatric Patient Outcomes. Ann Thorac Surg. 2016 Oct;102(4):1375-80. doi: 10.1016/j.athoracsur.2016.03.019. Epub 2016 May 10.