Trial Outcomes & Findings for Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE (NCT NCT04347941)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Up to 28 days post randomisation

Results posted on

2021-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Prone Positioning Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Ireland	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days post randomisation

Population: Number of patients who required invasive mechanical ventilation or who died in each group up to 28 days post randomization.

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.

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Daily during intervention up to 14 days post randomisation

Population: description of duration of prone positioning in hours per day from day 0 to day 14 in trial

description of duration of prone positioning in hours per day from day 0 to day 14 in trial

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
Length of Time Tolerating Prone Positioning	3.3 hours Standard Deviation 2.7	1.0 hours Standard Deviation 2.5

SECONDARY outcome

Timeframe: Immediately before intervention

Population: paO2 to fiO2 ratio before prone positioning in the group assigned to undergo awake prone positioning

Measure of change in oxygenation before intervention in the patients assigned to awake prone positioning

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
PaO2/FiO2 Ratio Measured Before Prone Positioning	144 ratio Standard Deviation 52	114 ratio Standard Deviation 40

SECONDARY outcome

Timeframe: During intervention

Population: change in paO2 one hour after proning in the individuals who were in the intervention group and underwent awake prone positioning

Measure of change in oxygenation following patients being placed in the prone position for 1 hour

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
PaO2/FiO2 Ratio After 1 Hours of Prone Positioning	33 ratio Standard Deviation 32	—

SECONDARY outcome

Timeframe: Immediately before intervention

Population: spO2 to fiO2 ratio at baseline prior to awake prone position in those undergoing awake prone position, and on the morning post enrolment for patients undergoing standard of care treatment

Measure of oxygenation using pulse oximetry before intervention where ABG not available

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
SpO2/FiO2 Ratio Measured Before Prone Positioning	193 ratio Standard Deviation 45	178 ratio Standard Deviation 52

SECONDARY outcome

Timeframe: During Intervention

Population: spO2 to fiO2 ratio following 1 hour in prone position

Measure of oxygenation 1 hour after intervention where ABG not available

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
SpO2/FiO2 Ratio After 1 Hour in Prone Positioning	247 ratio Standard Deviation 53	—

SECONDARY outcome

Timeframe: Up to 28 days post randomisation

Population: 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)

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)

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care n=12 Participants Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
Number Requiring Increase in Ventilatory Assistance	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediately before and during intervention

Population: We did not carry out this aspect of the study due to constraints related to the Pandemic

Measure of work of breathing in COVID-19 based on Oxygen Delivery Device, Oxygen Saturation and respiratory rate and accessory muscle use with 0-3 Mild, 4-6 Moderate and 7-10 Severe

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During intervention

Population: Due to constraints related to the pandemic, this aspect of the study was not carried out.

Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 days post randomisation

Population: Number of patients who underwent awake prone positioning in the control arm of the study as a rescue manoeuvre in response to hypoxia.

Number of patients who underwent rescue awake prone positioning in control patients by physicians in response to hypoxia

Outcome measures

Outcome measures
Measure	Prone Positioning n=12 Participants Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals Prone Positioning: Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula	Standard Care Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded. Standard of care.: Standard of care. Prone positioning may be administered as a rescue therapy
Use of Awake Prone Positioning as a Rescue Intervention in Control Patients	0 Participants	—

Adverse Events

Prone Positioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Bairbre McNicholas

National University of Ireland, Galway

Phone: +35391893063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place