Clinical trial NCT04347941: Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE
Official title: Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ARDS, Human
Mechanical Ventilation Complication
COVID19
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Prone positioning (PP) is an adjunctive therapy used that has been proven to save lives in sedated patients with confirmed moderate-severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (MV). PP involves placing patients in the prone, i.e. face down position for time periods of up to 16 hours per day. PP promotes lung homogeneity, improves gas exchange and respiratory mechanics permitting reduction of ventilation intensity, and reducing ventilator-induced lung injury (VILI).

Maintaining self-ventilation is associated with increased aeration of dependent lung regions, less need for sedation, improved cardiac filling and removes the risk of VILI, and so is an important therapeutic goal in hypoxic patients. The use of PP in awake self-ventilating patients with COVID-19 induced acute hypoxic respiratory failure (AHRF) and/or ARDS could improve gas exchange and reduce the need for invasive MV, but has not been studied outside of case series.

However, an increase in oxygenation does not necessarily reduce the risk of invasive MV. PP has significant attached risks such as causing pressure sores in patients, PP is uncomfortable for some patients, it increases nursing workload, and if ineffective could hinder the delivery of other (effective) medical care. Hence there is a need to determine if PP of awake patients is effective in reducing the need for invasive MV. This multi-centre, open label, randomized controlled study of COVID-19 induced AHRF/ARDS will determine if PP reduces the need for mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed COVID19 infection
* Bilateral Infiltrates on CXR
* SpO2 \<94% on FiO2 40% by either venturi facemask or high flow nasal cannula
* RR \<40
* Written informed consent

Exclusion Criteria:

* Age \<18
* Uncooperative or likely to be unable to lie on abdomen for 16 hours
* Receiving comfort care only
* Multi-organ failure
* RR\>40
* Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy \>20/40 gestation, severe brain injury).

Primary outcomes:
measure: The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.
timeFrame: Up to 28 days post randomisation
Secondary outcomes:
measure: Length of Time Tolerating Prone Positioning
timeFrame: Daily during intervention up to 14 days post randomisation
measure: PaO2/FiO2 Ratio Measured Before Prone Positioning
timeFrame: Immediately before intervention
measure: PaO2/FiO2 Ratio After 1 Hours of Prone Positioning
timeFrame: During intervention
measure: SpO2/FiO2 Ratio Measured Before Prone Positioning
timeFrame: Immediately before intervention
measure: SpO2/FiO2 Ratio After 1 Hour in Prone Positioning
timeFrame: During Intervention
measure: Number Requiring Increase in Ventilatory Assistance
timeFrame: Up to 28 days post randomisation
measure: Work of Breathing Assessment (Respiratory Distress Scale)
timeFrame: Immediately before and during intervention
measure: Changes in Bioimpedance Measures of Lung Edema in Patients in PP
timeFrame: During intervention
measure: Use of Awake Prone Positioning as a Rescue Intervention in Control Patients
timeFrame: Up to 28 days post randomisation
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
References:
citation: Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
citation: Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.