Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

NCT ID: NCT02622152

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Defects, Congenital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Right lateral position (2 hours)

Intervention Type PROCEDURE

Repositioning the patients for two-hours period on the right lateral position

Left lateral position (30 minutes)

Intervention Type PROCEDURE

Repositioning the patients for 30 minutes period on the left lateral position

Supine position (30 minutes)

Intervention Type PROCEDURE

Repositioning the patients for 30 minutes period on the supine position

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

Group Type ACTIVE_COMPARATOR

Right lateral position (2 hours)

Intervention Type PROCEDURE

Repositioning the patients for two-hours period on the right lateral position

Left lateral position (2 hours)

Intervention Type PROCEDURE

Repositioning the patients for two-hours period on the left lateral position

Supine position (2 hours)

Intervention Type PROCEDURE

Repositioning the patients for two-hours period on supine position

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Right lateral position (2 hours)

Repositioning the patients for two-hours period on the right lateral position

Intervention Type PROCEDURE

Left lateral position (30 minutes)

Repositioning the patients for 30 minutes period on the left lateral position

Intervention Type PROCEDURE

Supine position (30 minutes)

Repositioning the patients for 30 minutes period on the supine position

Intervention Type PROCEDURE

Left lateral position (2 hours)

Repositioning the patients for two-hours period on the left lateral position

Intervention Type PROCEDURE

Supine position (2 hours)

Repositioning the patients for two-hours period on supine position

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sayed abd elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

sayed abd-elshafy, MD

Role: CONTACT

0020882413203

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

mohamed abdelatef, MD

Role: primary

0020882413201

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB0000871200

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.