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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Completed

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

Treatments: Procedure: 30° Head-Elevated Prone Positioning; Procedure: 45° Head-Elevated Prone Positioning; Procedure: 10° Head-Elevated Prone Positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT07323979

KY-Z-2022-311-04

KD022024023 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

10° Head-Elevated Prone Position

Experimental group

Description:

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.

Treatment:

Procedure: 10° Head-Elevated Prone Positioning

30° Head-Elevated Prone Position

Experimental group

Description:

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.

Treatment:

Procedure: 30° Head-Elevated Prone Positioning

45° Head-Elevated Prone Position

Experimental group

Description:

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.

Treatment:

Procedure: 45° Head-Elevated Prone Positioning