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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Hypoxia; Respiratory Insufficiency; Heart Defects, Congenital; CHD
• Intervention / Treatment: Procedure: 10° Head-Elevated Prone Positioning; Procedure: 30° Head-Elevated Prone Positioning; Procedure: 45° Head-Elevated Prone Positioning

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Compliance		Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
Oxygenation Index (OI)	The Oxygenation Index is a measure used to assess the severity of hypoxic respiratory failure and lung function recovery. It is calculated using the formula: OI = (FiO2 × Mean Airway Pressure × 100) / PaO2. Arterial blood gases (PaO2) are obtained from arterial lines, and FiO2 and mean airway pressure are recorded from the ventilator. Lower scores indicate better oxygenation status.	Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
Airway Resistance	Airway resistance is measured by the mechanical ventilator to assess the resistance of the respiratory tract to airflow. Lower values indicate better airway patency and less obstruction. Unit: cmH2O/L/s.	Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Residual Volume (GRV)	Gastric residual volume is assessed by aspirating gastric contents through the nasogastric tube before feeding. It serves as a key indicator of enteral nutrition tolerance and gastric emptying function. Lower volumes indicate better tolerance and faster gastric emptying. Unit: mL.	Baseline (0 hours), 6 hours, and 12 hours after initiation of prone positioning.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Congenital Abnormalities; Signs and Symptoms, Respiratory; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Insufficiency; Heart Defects, Congenital; Hypoxia; Postoperative Complications
• Other Study ID Numbers: KY-Z-2022-311-04; KD022024023 (Other Grant/Funding Number: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Privacy confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No