18 and older, any sex, with ARDS, Human or Mechanical Ventilation Complication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.Primary· Up to 28 days post randomisation
A measure of effect of awake prone positioning in patients with confirmed or suspected COVID-19 acute hypoxemic respiratory failure undergoing supplemental oxygen via high flow nasal cannular oxygen on reducing requirement for invasive mechanical ventilation or death. Outcome measure is calculated as a count of the number of patients who went onto require invasive mechanical ventilation or died up to 28 days post randomization.
Group
Value
95% CI
Prone Positioning
0
Standard Care
2
Length of Time Tolerating Prone PositioningSecondary· Daily during intervention up to 14 days post randomisation
description of duration of prone positioning in hours per day from day 0 to day 14 in trial
Group
Value
95% CI
Prone Positioning
3.3
± 2.7
Standard Care
1.0
± 2.5
PaO2/FiO2 Ratio Measured Before Prone PositioningSecondary· Immediately before intervention
Measure of change in oxygenation before intervention in the patients assigned to awake prone positioning
Group
Value
95% CI
Prone Positioning
144
± 52
Standard of Care
114
± 40
PaO2/FiO2 Ratio After 1 Hours of Prone PositioningSecondary· During intervention
Measure of change in oxygenation following patients being placed in the prone position for 1 hour
Group
Value
95% CI
Prone Positioning
33
± 32
SpO2/FiO2 Ratio Measured Before Prone PositioningSecondary· Immediately before intervention
Measure of oxygenation using pulse oximetry before intervention where ABG not available
Group
Value
95% CI
Prone Positioning
193
± 45
Standard of Care
178
± 52
SpO2/FiO2 Ratio After 1 Hour in Prone PositioningSecondary· During Intervention
Measure of oxygenation 1 hour after intervention where ABG not available
Group
Value
95% CI
Prone Positioning
247
± 53
Number Requiring Increase in Ventilatory AssistanceSecondary· Up to 28 days post randomisation
Number of patients in each group requiring an increase in the respiratory support from baseline high flow nasal cannula oxygen post randomization up to 28 days later, defined as need for continuous positive airway pressure (CPAP), bilevel positive airway pressure (biPAP)
Group
Value
95% CI
Prone Positioning
4
Standard Care
4
Use of Awake Prone Positioning as a Rescue Intervention in Control PatientsSecondary· Up to 28 days post randomisation
Number of patients who underwent rescue awake prone positioning in control patients by physicians in response to hypoxia
Group
Value
95% CI
Standard Care
0
Sponsor's own description
Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05535543 — Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
· recruiting
NCT04517123 — Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
· NA
· completed
NCT04424797 — Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol
· NA
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University College Hospital Galway
Last refreshed: 2 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04347941.