CHDPACE-CHDNCT07323979
The Effects of Different Prone Positioning Angles on Cardiopulmonary Function in Children After Congenital Heart Disease Surgery: A Randomized Controlled Trial
A study testing 10° Head-Elevated Prone Positioning, 30° Head-Elevated Prone Positioning and 45° Head-Elevated Prone Positioning in people with CHD and Heart Defects, Congenital, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- CHD, Heart Defects, Congenital, Hypoxia
- What is being tested?
- 10° Head-Elevated Prone Positioning, 30° Head-Elevated Prone Positioning and 45° Head-Elevated Prone Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
- 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?
- Does increasing the elevation angle improve the tolerance of enteral nutrition (tube feeding) while maintaining patient safety?
Read more
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:
- Be randomly assigned to one of three groups: 10°, 30°, or 45° head-elevated prone position.
- Maintain the assigned prone position for at least 12 hours daily.
- 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
- Being tested
- 10° Head-Elevated Prone Positioning, 30° Head-Elevated Prone Positioning, 45° Head-Elevated Prone Positioning
- Medical subject headings
- Heart Defects, Congenital, Hypoxia, Respiratory Insufficiency, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10° Head-Elevated Prone PositioningProcedure or surgery
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 PositioningProcedure or surgery
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 PositioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: 45° Head-Elevated Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Compliance
Measured: 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.
Measured: 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.
Measured: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
Secondary outcomes (1)
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.
Measured: Baseline (0 hours), 6 hours, and 12 hours after initiation of prone positioning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start20 Apr 2023
- Primary completion8 May 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323979
- Sponsor's protocol ID
- KY-Z-2022-311-04
- Other IDs
- KD022024023
- Acronym
- PACE-CHD
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Prone Positioning Angles on Cardiopulmonary Function in Children After Congenital Heart Disease Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07323979
- Acronym / sponsor ID
- PACE-CHD / KY-Z-2022-311-04
- Conditions
- CHD, Heart Defects, Congenital, Hypoxia, Respiratory Insufficiency, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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:
- Be randomly assigned to one of three groups: 10°, 30°, or 45° head-elevated prone position.
- Maintain the assigned prone position for at least 12 hours daily.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10° Head-Elevated Prone Position | Experimental | Procedure: 10° Head-Elevated Prone PositioningParticipants 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. |
| 30° Head-Elevated Prone Position | Experimental | Procedure: 30° Head-Elevated Prone PositioningParticipants 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. |
| 45° Head-Elevated Prone Position | Experimental | Procedure: 45° Head-Elevated Prone PositioningParticipants 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. |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10° Head-Elevated Prone PositioningParticipants 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. | Procedure or surgery | 10° Head-Elevated Prone Position |
| 30° Head-Elevated Prone PositioningParticipants 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. | Procedure or surgery | 30° Head-Elevated Prone Position |
| 45° Head-Elevated Prone PositioningParticipants 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. | Procedure or surgery | 45° Head-Elevated Prone Position |
Primary outcome
Lung Compliance
Time frame: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
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.
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.
1 secondary outcome
Gastric Residual Volume (GRV)
Time frame: Baseline (0 hours), 6 hours, and 12 hours after initiation of prone positioning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided. Privacy confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10° Head-Elevated Prone Positioning, 30° Head-Elevated Prone Positioning and 45° Head-Elevated Prone Positioning in people with CHD and Heart Defects, Congenital, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Compliance (time frame: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.