Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622152
• Other study ID #: IRB0000871200
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: sayed abd-elshafy, MD
• Phone: 0020882413203
• Email: sayed_k_72[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Procedure:
• Right lateral position (2 hours)
Repositioning the patients for two-hours period on the right lateral position
• Left lateral position (30 minutes)
Repositioning the patients for 30 minutes period on the left lateral position
• Supine position (30 minutes)
Repositioning the patients for 30 minutes period on the supine position
• Left lateral position (2 hours)
Repositioning the patients for two-hours period on the left lateral position
• Supine position (2 hours)
Repositioning the patients for two-hours period on supine position

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Heart rate	Heart rate "beats per minute"	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Secondary	Oxygen saturation	Oxygen saturation %	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Secondary	Respiratory rate	Respiratory rate "rate per minute"	Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days