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| ID | Type | Description | Link |
|---|---|---|---|
| KD022024023 | Other Grant/Funding Number | Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
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:
Active bleeding.
Significant pneumothorax.
Delayed sternal closure.
Transfer to another facility or death before completing the protocol.
Withdrawal of consent by legal guardians.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
Privacy confidentiality
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people processing the numbers (statisticians) and recording the numbers (data collectors)
|
| 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D000860 | Hypoxia |
| D012131 | Respiratory Insufficiency |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
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