The Effect of Different Positions in Children After Cardiac Surgery

NCT05393128 | Completed

• 1 other identifier: ATADEK-2021/21
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant ALL

Keywords

pediatric heart surgery; position; infant

Outcome Measures

Primary Outcomes (5)

• Change in Body Temperature

  This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary.

  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.

• Change in Heart Rate

  Heart rate will be monitored.

  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.

• Change in Blood Pressure

  Blood Pressure will be monitored.

  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.

• Change in Respiratory Rate

  Respiratory rate will be monitored.

  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.

• Change in Oxygen Saturation

  Oxygen Saturation will be monitored.

  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.

Study Arms (3)

Control group (Supine position)

OTHER

The patient will remain in the supine position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the supine position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

Procedure: Control group (Supine Position)

Experimental Group (Right lateral position)

EXPERIMENTAL

The patient will remain in the right lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the right lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

Procedure: Experimental Group (Right Lateral position)

Experimental Group (Left lateral position)

EXPERIMENTAL

The patient will remain in the left lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the left lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

Procedure: Experimental Group (Left Lateral position)

Interventions

Control group (Supine Position) PROCEDURE

In this group the patients will be given supine position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be given supine position. 3. The arms and the hands will be elevated and supported, the legs will be elevated and supported. 4. The patient will be covered. 5. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

Control group (Supine position)

Experimental Group (Right Lateral position) PROCEDURE

In this group the patients will be given right lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the right side of the patient and the patient will be turned with 60-90 degrees right lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

Experimental Group (Right lateral position)

Experimental Group (Left Lateral position) PROCEDURE

In this group the patients will be given left lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the left side of the patient and the patient will be turned with 60-90 degrees left lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital findings, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

Experimental Group (Left lateral position)

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Education and Research Hospital

Istanbul, Kadıköy, 34734, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21894418 RESULT

• 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.

  PMID: 17444315 RESULT

• 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.

  PMID: 17402946 RESULT

• 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.

  PMID: 27173065 RESULT

MeSH Terms

Interventions

Control Groups; Supine Position

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zehra Kan Öntürk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Assist. Prof.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: May 26, 2022
• Study Start: March 17, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)