Clinical trial NCT04477655: Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure
Official title: Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID-19
Severe
Prone positioning
High-flow nasal cannula
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.

Detailed description: Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the treatment of moderate/severe disease is mainly supportive, including oxygen therapy and invasive mechanical ventilation when impending respiratory failure is established. Moreover, the associated mortality among mechanically intubated patients is overwhelmingly high. Prone position relieves the dependent lung regions from the compressive forces of the mediastinum's weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung regions. According to a few case series, and observational non-randomized studies with small sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during prone positioning, however there are no clinical evidence that this improvement is associated with a decrease in the risk of invasive mechanical ventilation. Considering that prone positioning is a low cost, low risk and widely available therapy, more high quality evidence is needed, to determine if the benefits of prone positioning in awake patients also include a lower requirement of mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Adult patients with confirmed COVID-19, and requirement of a fraction of inspired oxygen (FiO2) ≥30% through high-flow nasal cannula (HFNC) to maintain a capillary saturation of ≥90%

Exclusion Criteria:

* Less than 18 years-old
* Pregnancy
* Patients with immediate need of invasive mechanical ventilation
* Contraindications for prone positioning therapy
* Do-not-resuscitate or do-not-intubate order
* Refusal of the patient or decision maker to enroll in the study

Primary outcomes:
measure: Intubation rate
timeFrame: 28 days
Secondary outcomes:
measure: Total hours of prone position at day
timeFrame: 28 days
measure: Total number of prone sessions at day
timeFrame: 28 days
measure: Hours of the longest prone session each day
timeFrame: 28 days
measure: Change in oxygenation 1-hour after first prone session
timeFrame: 1 hour
measure: Change in the ROX-index 1-hour after first prone session
timeFrame: 1 hour
measure: Total days of prone positioning therapy
timeFrame: 28 days
measure: Adverse effects of prone positioning therapy
timeFrame: 28 days
measure: Mechanical ventilation days
timeFrame: 28 days
measure: Intensive care unit length of stay
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: 28 days
measure: Hospital mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital General de Occidente
state: Jalisco
Study officials:
affiliation: Investigator
name: Miguel Ibarra-Estrada
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibarra-Estrada M, Li J, Pavlov I, Perez Y, Roca O, Tavernier E, McNicholas B, Vines D, Marin-Rosales M, Vargas-Obieta A, Garcia-Salcido R, Aguirre-Diaz SA, Lopez-Pulgarin JA, Chavez-Pena Q, Mijangos-Mendez JC, Aguirre-Avalos G, Ehrmann S, Laffey JG. Factors for success of awake prone positioning in patients with COVID-19-induced acute hypoxemic respiratory failure: analysis of a randomized controlled trial. Crit Care. 2022 Mar 28;26(1):84. doi: 10.1186/s13054-022-03950-0.
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: Ibarra-Estrada MA, Marin-Rosales M, Garcia-Salcido R, Aguirre-Diaz SA, Vargas-Obieta A, Chavez-Pena Q, Lopez-Pulgarin JA, Mijangos-Mendez JC, Aguirre-Avalos G. Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 23;21(1):940. doi: 10.1186/s13063-020-04882-2.