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Completed

NCT Number: NCT07421635

Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Receiving Prone Position Ventilation

Evidence remains limited regarding the optimal enteral nutrition (EN) route for acute respiratory distress syndrome (ARDS) patients undergoing prone positioning. This study aimed to explore the association of post-pyloric feeding with feeding intolerance (FI), specifically in that population.

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Key information

Conditions

Clinical Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This single-center retrospective study included adult patients with ARDS who received prone position ventilation at Zhongda Hospital, Southeast University, between July 30, 2016, and April 30, 2024. The primary outcome was the incidence of FI, defined as the failure to achieve an enteral energy intake of 17.5 kcal/kg/day within 72 hours of initiating EN. The statistical approaches utilized included multivariate regression, inverse probability weighting model, and marginal structural cox model to ensure the robustness of our findings. Subgroup analyses were also performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 years old
  • ARDS, defined by the Berlin standard
  • patients receiving prone position ventilation treatment

Exclusion criteria

  • No enteral nutrition within 4 days after initiation of invasive mechanical ventilation
  • Duration of invasive mechanical ventilation <72 hours after initiation of enteral nutrition
  • Prone positioning initiated >3 days after EN
  • Duration of each prone session <12 hours
  • Severe acute pancreatitis
  • Contraindications to early enteral nutrition

Treatment and study plan

Primary outcomes

  1. Incidence of FI

    Time frame: at day 3

    Incidence of feeding intolerance during enteral nutrition within 72 hours of initiating EN

Secondary outcomes

  1. Incidence of enteral nutrition-related complications

    Time frame: up to 3 days

    Incidence of feeding-related complications during enteral nutrition

  2. ICU mortality

    Time frame: up to 24 months

    the survival rate(survival/total) during ICU stay

  3. 28-day mortality

    Time frame: at day 28

    mortality in Day 28

  4. VFDs at day 28

    Time frame: 28 days

    defined as the number of days between successful weaning from MV and day 28 after study enrollment

  5. Length of ICU stay

    Time frame: up to 24 months

    the number of days from ICU admission to ICU discharge or death

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Post-pyloric Feeding and Feeding Intolerance in ARDS Patients Undergoing Prone Position Ventilation: a Single-center, Retrospective Study

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2026
Registry last updated
Mar 30, 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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