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New treatment option for ARDS
Official title Enteral Nutrition Delivery in Prone Position Ventilated Patients With Moderate to Severe ARDS
ClinicalTrials.gov ID: NCT07362537
What this study is testing
- What it's testing
- This pilot study is aimed to compare and assess the impact, safety, and practical utility of gastric versus postpyloric feeding in moderate to severe ARDS patients with prone position ventilation. Patients included will be randomly assigned to receive enteral nutrition either through a nasogastric tube or a nasojejunal tube.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio ≤ 200mmHg.
- Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning...
- Patients planned to receive enteral nutrition.
- Age ≥18 and ≤85 years.
- Consent to sign an informed consent form.
You likely can't join if
- Contraindications to enteral nutrition, such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula...
- Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage ≥0.5ug/kg.min) or tissue hypoperfusion (lactate...
- Life-threatening hypoxemia, hypercapnia, and acidosis.
- Inability to tolerate prone ventilation (e.g., pregnant women, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker...
- Conditions preventing nasogastric or nasojejunal tube placement (e.g., esophageal rupture, severe esophageal varices).
- Anticipated inability to start enteral nutrition within 48 hours.
See the full eligibility criteria
- ARDS patients who meet the Berlin criteria for ARDS and have a P/F ratio ≤ 200mmHg.
- Patients receiving invasive mechanical ventilation and clinically judged to require prone ventilation, with an anticipated daily prone positioning time of ≥12 hours and a duration of prone ventilation therapy of ≥3 days.
- Patients planned to receive enteral nutrition.
- Age ≥18 and ≤85 years.
- Consent to sign an informed consent form.
- Contraindications to enteral nutrition, such as severe intestinal ischemia, active upper gastrointestinal bleeding, high-output intestinal fistula without a distal feeding route, abdominal compartment syndrome, severe...
- Presence of shock with hemodynamic instability (norepinephrine or equivalent vasopressor dosage ≥0.5ug/kg.min) or tissue hypoperfusion (lactate \>3mmol/L).
- Life-threatening hypoxemia, hypercapnia, and acidosis.
- Inability to tolerate prone ventilation (e.g., pregnant women, limb contractures, recent fractures, recent thoracic or abdominal surgery, pacemaker insertion within 48 hours, spinal instability, pelvic fractures, facial...
- Conditions preventing nasogastric or nasojejunal tube placement (e.g., esophageal rupture, severe esophageal varices).
- Anticipated inability to start enteral nutrition within 48 hours.
- Use of prokinetic agents within 48 hours prior to starting enteral nutrition.
- Enteral nutrition via gastrostomy or jejunostomy.
- Expected ICU stay or survival time less than 3 days.
- Patients refusing further resuscitative treatment.
- Pregnant or breastfeeding women.
- Patients already enrolled in other treatment clinical studies or deemed unsuitable for the study by the clinician.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.