Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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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
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Sixty pediatric congenital heart disease patients were randomly assigned to two equal intervention groups

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

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right lateral, Oxygenation, Cardiac, Congenital, Pediatric, Postoperative