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Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Primary Purpose

Heart Defects, Congenital

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Right lateral position (2 hours)
Left lateral position (30 minutes)
Supine position (30 minutes)
Left lateral position (2 hours)
Supine position (2 hours)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Defects, Congenital focused on measuring Right lateral, Oxygenation, Cardiac, Congenital, Pediatric, Postoperative

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Right lateral position group

Routine hospital care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Arterial oxygenation
The samples will be analyzed by a blood gas analyzer before and after changing position

Secondary Outcome Measures

Blood pressure
Systolic, diastolic and mean blood pressure " mm Hg"
Heart rate
Heart rate "beats per minute"
Oxygen saturation
Oxygen saturation %
Respiratory rate
Respiratory rate "rate per minute"

Full Information

First Posted
November 28, 2015
Last Updated
July 6, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02622152
Brief Title
Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery
Official Title
Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery: Effect on Arterial Oxygenation, Respiratory Mechanics, Hemodynamics, and Adverse Events
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2016 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
Right lateral, Oxygenation, Cardiac, Congenital, Pediatric, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Right lateral position group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Routine hospital care group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Right lateral position (2 hours)
Intervention Description
Repositioning the patients for two-hours period on the right lateral position
Intervention Type
Procedure
Intervention Name(s)
Left lateral position (30 minutes)
Intervention Description
Repositioning the patients for 30 minutes period on the left lateral position
Intervention Type
Procedure
Intervention Name(s)
Supine position (30 minutes)
Intervention Description
Repositioning the patients for 30 minutes period on the supine position
Intervention Type
Procedure
Intervention Name(s)
Left lateral position (2 hours)
Intervention Description
Repositioning the patients for two-hours period on the left lateral position
Intervention Type
Procedure
Intervention Name(s)
Supine position (2 hours)
Intervention Description
Repositioning the patients for two-hours period on supine position
Primary Outcome Measure Information:
Title
Arterial oxygenation
Description
The samples will be analyzed by a blood gas analyzer before and after changing position
Time Frame
Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic, diastolic and mean blood pressure " mm Hg"
Time Frame
Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Title
Heart rate
Description
Heart rate "beats per minute"
Time Frame
Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Title
Oxygen saturation
Description
Oxygen saturation %
Time Frame
Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Title
Respiratory rate
Description
Respiratory rate "rate per minute"
Time Frame
Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sayed abd-elshafy, MD
Phone
0020882413203
Email
sayed_k_72@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy, MD
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed abdelatef, MD
Phone
0020882413201
Email
latif_mohamed@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

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