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

NCT07323979 | Completed DMC

• 2 other identifiers: KY-Z-2022-311-04KD022024023
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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. 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. 2.Does increasing the elevation angle improve the tolerance of enteral nutrition (tube feeding) while maintaining patient safety?
3. 3.Be randomly assigned to one of three groups: 10°, 30°, or 45° head-elevated prone position.
4. 4.Maintain the assigned prone position for at least 12 hours daily.
5. 5.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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Gastric Residual Volume (GRV)

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

Study Arms (3)

10° Head-Elevated Prone Position

EXPERIMENTAL

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

30° Head-Elevated Prone Position

EXPERIMENTAL

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

45° Head-Elevated Prone Position

EXPERIMENTAL

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

Interventions

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.

10° Head-Elevated Prone Position

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.

30° Head-Elevated Prone Position

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.

45° Head-Elevated Prone Position

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: people processing the numbers (statisticians) and recording the numbers (data collectors)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: April 20, 2023
• Primary Completion: May 8, 2025
• Study Completion: July 10, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

CN (1)