The Effects of Different Prone Positioning Angles on Cardiopulmonary Function in Children After Congenital Heart Disease Surgery: A Randomized Controlled Trial

NCT ID: NCT07323979

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2025-07-10

Brief Summary

The goal of this randomized controlled trial is to learn if different head-elevated prone positioning angles can optimize cardiopulmonary function and enteral nutrition tolerance in infants and children after congenital heart disease (CHD) surgery. The main questions it aims to answer are:

1. Do specific prone positioning angles (10°, 30°, or 45°) lead to better improvements in cardiopulmonary recovery, specifically regarding oxygenation, lung compliance, airway resistance, and hemodynamic stability?

2. Does increasing the elevation angle improve the tolerance of enteral nutrition (tube feeding) while maintaining patient safety?

Researchers will compare three different head-of-bed elevation angles (10°, 30°, and 45°) to see if a specific angle offers superior heart and lung support and nutritional benefits during the early postoperative period.

Participants will:

1. Be randomly assigned to one of three groups: 10°, 30°, or 45° head-elevated prone position.

2. Maintain the assigned prone position for at least 12 hours daily.

3. Undergo monitoring of cardiopulmonary indicators (including oxygen levels, ventilator parameters, blood pressure, and central venous pressure) and digestive function (gastric residual volume) at scheduled intervals (0, 4, 6, and 12 hours).

Conditions

CHD; Heart Defects, Congenital; Hypoxia; Respiratory Insufficiency; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

10° Head-Elevated Prone Position

Participants assigned to this group receive prone positioning therapy with the head of the bed elevated to an angle of 10 degrees. The angle is calibrated using a protractor. The prone position is maintained for at least 12 hours per day.

Group Type: EXPERIMENTAL

10° Head-Elevated Prone Positioning

Intervention Type: PROCEDURE

Participants receive prone positioning therapy with the head of the bed elevated strictly to 10 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

30° Head-Elevated Prone Position

Participants assigned to this group receive prone positioning therapy with the head of the bed elevated to an angle of 30 degrees. The angle is calibrated using a protractor. The prone position is maintained for at least 12 hours per day.

Group Type: EXPERIMENTAL

30° Head-Elevated Prone Positioning

Intervention Type: PROCEDURE

Participants receive prone positioning therapy with the head of the bed elevated strictly to 30 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

45° Head-Elevated Prone Position

Participants assigned to this group receive prone positioning therapy with the head of the bed elevated to an angle of 45 degrees. The angle is calibrated using a protractor. The prone position is maintained for at least 12 hours per day.

Group Type: EXPERIMENTAL

45° Head-Elevated Prone Positioning

Intervention Type: PROCEDURE

Participants receive prone positioning therapy with the head of the bed elevated strictly to 45 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

Interventions

10° Head-Elevated Prone Positioning

Participants receive prone positioning therapy with the head of the bed elevated strictly to 10 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

Intervention Type: PROCEDURE

30° Head-Elevated Prone Positioning

Participants receive prone positioning therapy with the head of the bed elevated strictly to 30 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

Intervention Type: PROCEDURE

45° Head-Elevated Prone Positioning

Participants receive prone positioning therapy with the head of the bed elevated strictly to 45 degrees, verified by a protractor. The position is maintained for at least 12 hours daily. The head position is alternated every 2 hours, and arms are placed alongside the torso.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Congenital Heart Disease (CHD) confirmed by echocardiography with surgery performed.

RACHS-1 score ≥ 2.

Postoperative acute hypoxemia, defined as PaO2/FiO2 ≤ 100 mmHg with bilateral infiltrates.

Receiving invasive mechanical ventilation.

Nasogastric or nasoenteric tube in place.

Hemodynamic stability for ≥ 72 hours (inotropic score ≤ 25).

Exclusion Criteria

• Cardiac arrest or age-specific bradycardia (> 20% below normal).

Active bleeding.

Significant pneumothorax.

Delayed sternal closure.

Transfer to another facility or death before completing the protocol.

Withdrawal of consent by legal guardians.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

KY-Z-2022-311-04

Identifier Type: -

Identifier Source: org_study_id

KD022024023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id