Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery: Effect on Arterial Oxygenation, Respiratory Mechanics, Hemodynamics, and Adverse Events

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.

Study Overview

• Status: Unknown
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Procedure: Right lateral position (2 hours); Procedure: Left lateral position (30 minutes); Procedure: Supine position (30 minutes); Procedure: Left lateral position (2 hours); Procedure: Supine position (2 hours)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sayed abd-elshafy, MD; Phone Number: 0020882413203; Email: sayed_k_72@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right lateral position group; 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	Procedure: Right lateral position (2 hours); Repositioning the patients for two-hours period on the right lateral position; Procedure: Left lateral position (30 minutes); Repositioning the patients for 30 minutes period on the left lateral position; Procedure: Supine position (30 minutes); Repositioning the patients for 30 minutes period on the supine position
Active Comparator: Routine hospital care group; 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	Procedure: Right lateral position (2 hours); Repositioning the patients for two-hours period on the right lateral position; Procedure: Left lateral position (2 hours); Repositioning the patients for two-hours period on the left lateral position; Procedure: Supine position (2 hours); Repositioning the patients for two-hours period on supine position

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 28, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; Postoperative; Cardiac; Oxygenation; Congenital; Right lateral
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: IRB0000871200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided