Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Not Applicable

• Conditions: Heart Defects, Congenital
• Interventions: Procedure: Right lateral position (2 hours); Procedure: Left lateral position (30 minutes); Procedure: Left lateral position (2 hours); Procedure: Supine position (2 hours); Procedure: Supine position (30 minutes)

• Registration Number: NCT02622152
• Lead Sponsor: Assiut University

Brief Summary

Directly following cardiac surgery for congenital heart disease; patients are not receiving routine turning every two hours to prevent pressure ulcers, because a negative influence on hemodynamic parameters is assumed. Investigators have suggested that lateral position may have clinically significant effects on oxygenation in cardiac surgery patients.

Detailed Description

Sixty pediatric congenital heart disease patients were randomly assigned to two equal intervention groups

Study Timeline

• Study First Submitted: 2015-11-28
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Study Start: 2016-01-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age within 10 years with a cyanotic congenital heart disease
• Hemodynamic stability with no compromising arrhythmia
• No respiratory arrest
• Not connected with mechanical ventilation

Exclusion Criteria

• Cyanotic congenital heart disease
• Hemodynamic instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine hospital care group	Supine position (2 hours)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for two-hours period on supine position Repositioning the patients for two-hours period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay
Right lateral position group	Right lateral position (2 hours)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for 30 minutes period on the supine position Repositioning the patients for 30 minutes period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay
Right lateral position group	Left lateral position (30 minutes)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for 30 minutes period on the supine position Repositioning the patients for 30 minutes period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay
Right lateral position group	Supine position (30 minutes)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for 30 minutes period on the supine position Repositioning the patients for 30 minutes period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay
Routine hospital care group	Right lateral position (2 hours)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for two-hours period on supine position Repositioning the patients for two-hours period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay
Routine hospital care group	Left lateral position (2 hours)	After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for two-hours period on supine position Repositioning the patients for two-hours period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay

Primary Outcome Measures

Name	Time	Method
Arterial oxygenation	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days	The samples will be analyzed by a blood gas analyzer before and after changing position

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days	Oxygen saturation %
Blood pressure	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days	Systolic, diastolic and mean blood pressure " mm Hg"
Heart rate	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days	Heart rate "beats per minute"
Respiratory rate	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days	Respiratory rate "rate per minute"

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt