Characteristics and Outcomes of Patients With COVID-19 Treated With HFNO and Prone Positioning

NCT05178212 | Completed DMC

• 1 other identifier: AW-PP_Covid-19
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). The use of high-flow nasal oxygen therapy (HFNO) and awake prone position (AW-PP) could to decrease the need for endotracheal intubation and other adverse clinical outcomes (4-6). The aim of this study is to evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.

Conditions

Mortality; Endotracheal Intubation; COVID-19; Respiratory Failure; Prone Position

Outcome Measures

Primary Outcomes (1)

• Endotracheal Intubation

  Requirement of endotracheal intubation according to the criteria of previous studies (9,10).

  Up to 4 weeks

Secondary Outcomes (1)

• In-hospital mortality.

  Up to 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We included patients older than 17 years admitted to the ICU with a confirmed diagnosis of COVID-19 (real-time PCR) and receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: a) peripheral oxygen saturation (SpO2) \< 92% with oxygen \> 4 liters/minute; b) increased work of breathing with use of accessory respiratory muscles, and a respiratory rate \> 30/min; c) PaO2/FiO2ratio \< 200 mmHg. Patients with respiratory failure secondary to a different etiology, decreased level of consciousness, presence of shock requiring vasopressors, immediate need for intubation, use of positive-pressure ventilation prior to HFNO, and with do-not intubate orders were excluded.

You may qualify if:

• Older than 17 years, admitted to the ICU
• Confirmed diagnosis of COVID-19 (real-time PCR)
• Receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: peripheral oxygen saturation (SpO2) \< 92% with oxygen \> 4 liters/minute; increased work of breathing with use of accessory respiratory muscles, and a respiratory rate \> 30/min; PaO2/FiO2ratio \< 200 mmHg.

You may not qualify if:

• Patients with respiratory failure secondary to a different etiology,
• Decreased level of consciousness,
• Presence of shock requiring vasopressors,
• Immediate need for intubation.
• Use of positive-pressure ventilation prior to HFNO, and f) with do-not intubate orders.

Sponsors & Collaborators

• Austral University, Argentina: collaborator
• Hospital Privado de Comunidad de Mar del Plata: lead
• Hospital Aleman: collaborator

Study Sites (1)

Mariano Esperatti

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Related Publications (12)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 RESULT

• Karagiannidis C, Mostert C, Hentschker C, Voshaar T, Malzahn J, Schillinger G, Klauber J, Janssens U, Marx G, Weber-Carstens S, Kluge S, Pfeifer M, Grabenhenrich L, Welte T, Busse R. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020 Sep;8(9):853-862. doi: 10.1016/S2213-2600(20)30316-7. Epub 2020 Jul 28.

  PMID: 32735842 RESULT

• Ranzani OT, Bastos LSL, Gelli JGM, Marchesi JF, Baiao F, Hamacher S, Bozza FA. Characterisation of the first 250,000 hospital admissions for COVID-19 in Brazil: a retrospective analysis of nationwide data. Lancet Respir Med. 2021 Apr;9(4):407-418. doi: 10.1016/S2213-2600(20)30560-9. Epub 2021 Jan 15.

  PMID: 33460571 RESULT

• Tan W, Xu DY, Xu MJ, Wang ZF, Dai B, Li LL, Zhao HW, Wang W, Kang J. The efficacy and tolerance of prone positioning in non-intubation patients with acute hypoxemic respiratory failure and ARDS: a meta-analysis. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211009407. doi: 10.1177/17534666211009407.

  PMID: 33888007 RESULT

• Ponnapa Reddy M, Subramaniam A, Afroz A, Billah B, Lim ZJ, Zubarev A, Blecher G, Tiruvoipati R, Ramanathan K, Wong SN, Brodie D, Fan E, Shekar K. Prone Positioning of Nonintubated Patients With Coronavirus Disease 2019-A Systematic Review and Meta-Analysis. Crit Care Med. 2021 Oct 1;49(10):e1001-e1014. doi: 10.1097/CCM.0000000000005086.

  PMID: 33927120 RESULT

• Cardona S, Downing J, Alfalasi R, Bzhilyanskaya V, Milzman D, Rehan M, Schwartz B, Yardi I, Yazdanpanah F, Tran QK. Intubation rate of patients with hypoxia due to COVID-19 treated with awake proning: A meta-analysis. Am J Emerg Med. 2021 May;43:88-96. doi: 10.1016/j.ajem.2021.01.058. Epub 2021 Jan 27.

  PMID: 33550104 RESULT

• Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

  PMID: 30576221 RESULT

• Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, Panebianco V, Andreoli C, Colaiacomo MC, Zingaropoli MA, Ciardi MR, Mastroianni CM, Pugliese F, Alessandri F, Turriziani O, Ricci P, Catalano C. Chest CT score in COVID-19 patients: correlation with disease severity and short-term prognosis. Eur Radiol. 2020 Dec;30(12):6808-6817. doi: 10.1007/s00330-020-07033-y. Epub 2020 Jul 4.

  PMID: 32623505 RESULT

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 RESULT

• Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682.

  PMID: 33764378 RESULT

• Olmos M, Fuentes N, Busico M, Gallardo A, Vitali A, Costa ELV, Amato MBP, Bruhn A, Esperatti M; Argentine Collaborative Group on High Flow, Prone Positioning. Effectiveness of bundle of care on tolerance of awake-prone positioning in patients with acute respiratory failure. A multicenter observational study. Intensive Care Med. 2025 Feb;51(2):332-341. doi: 10.1007/s00134-025-07804-5. Epub 2025 Feb 17.

  PMID: 39961842 DERIVED

• Busico M, Fuentes NA, Gallardo A, Vitali A, Quintana J, Olmos M, Burns KEA, Esperatti M; Argentine Collaborative Group on High Flow and Prone Positioning. The Predictive Validity of the Berlin Definition of Acute Respiratory Distress Syndrome for Patients With COVID-19-Related Respiratory Failure Treated With High-Flow Nasal Oxygen: A Multicenter, Prospective Cohort Study. Crit Care Med. 2024 Jan 1;52(1):92-101. doi: 10.1097/CCM.0000000000006056. Epub 2023 Oct 16.

  PMID: 37846935 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mariano Esperatti, MD, PhD. Head of Section. Intensive Care Department. Hospital Privado de Comunidad. Mar del Plata. Argentina

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 5, 2022
• Study Start: April 15, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2022
• Last Updated: January 27, 2026

Record last verified: 2022-12

Locations

AR (1)