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NCT Number: NCT07323979

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

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).

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Key information

Conditions

CHD Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10° Head-Elevated Prone Positioning

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 Positioning

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 Positioning

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.

Primary outcomes

  1. Lung Compliance

    Time frame: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.

  2. Oxygenation Index (OI)

    Time frame: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.

    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.

  3. Airway Resistance

    Time frame: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.

    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.

Secondary outcomes

  1. Gastric Residual Volume (GRV)

    Time frame: Baseline (0 hours), 6 hours, and 12 hours after initiation of prone positioning.

    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.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Acronym: PACE-CHD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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