Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS

NCT04325906 | Completed Results FDA Device

• 1 other identifier: COVID-19-HFNC+PP
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.

Conditions

Prone Positioning; High Flow Nasal Cannula; Acute Respiratory Distress Syndrome; Corona Virus Infection

Outcome Measures

Primary Outcomes (3)

• Treatment Failure (Intubation or Death)

  the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment

  28 days

• Number of Participants With Intubation

  intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment

  28 days

• Mortality

  mortality of HFNC/HFNC+PP support within 28 days of study enrollment

  28 days

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  28 days of study enrollment

Study Arms (2)

high flow nasal cannula only

ACTIVE COMPARATOR

Receive high flow nasal cannula only

Device: high flow nasal cannula (HFNC)

HFNC plus prone positioning

EXPERIMENTAL

Receive high flow nasal cannula plus prone positioning

Device: high flow nasal cannula (HFNC); Procedure: Prone positioning (PP)

Interventions

high flow nasal cannula (HFNC) DEVICE

HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher \&Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.

HFNC plus prone positioning; high flow nasal cannula only

Prone positioning (PP) PROCEDURE

PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%.

HFNC plus prone positioning

Eligibility Criteria

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

You may qualify if:

• COVID-19 induced adult ARDS patients admitted to the medical ICU
• PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on HFNC treatment

You may not qualify if:

• If the patients have a consistent SpO2\<80% when on evaluation with a FiO2 of 0.6, or signs of respiratory fatigue (RR \> 40/min, PaCO2\> 50mmHg / pH\<7.30, and obvious accessory respiratory muscle use);
• Immediate need for intubation (PaO2/FiO2\< 50mmHg or SpO2/FiO2 \<90, unable to protect airway or mental status change);
• unstable hemodynamic status(SBP\<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
• unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
• chest trauma or any contraindication for PP
• pneumothorax
• age \< 18 years

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (11)

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

  PMID: 23688302 BACKGROUND

• Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.

  PMID: 32000806 BACKGROUND

• Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.

  PMID: 29068269 BACKGROUND

• Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.

  PMID: 27400909 BACKGROUND

• Respiratory care committee of Chinese Thoracic Society. [Expert consensus on preventing nosocomial transmission during respiratory care for critically ill patients infected by 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 20;17(0):E020. doi: 10.3760/cma.j.issn.1001-0939.2020.0020. Online ahead of print. Chinese.

  PMID: 32077661 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33177145 BACKGROUND

• Pavlov I, He H, McNicholas B, Perez Y, Tavernier E, Trump MW, Jackson JA, Zhang W, Rubin DS, Spiegel T, Hung A, Estrada MAI, Roca O, Vines DL, Cosgrave D, Mirza S, Laffey JG, Rice TW, Ehrmann S, Li J. Awake Prone Positioning in Non-Intubated Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19. Respir Care. 2022 Jan;67(1):102-114. doi: 10.4187/respcare.09191. Epub 2021 Jul 7.

  PMID: 34234032 BACKGROUND

• Li J, Pavlov I, Laffey JG, Roca O, Mirza S, Perez Y, McNicholas B, Cosgrave D, Vines D, Tavernier E, Ehrmann S. Meta-trial of awake prone positioning with nasal high flow therapy: Invitation to join a pandemic collaborative research effort. J Crit Care. 2020 Dec;60:140-142. doi: 10.1016/j.jcrc.2020.07.020. Epub 2020 Jul 24. No abstract available.

  PMID: 32799184 BACKGROUND

• 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.

  PMID: 34425070 RESULT

• Kaur R, Vines DL, Mirza S, Elshafei A, Jackson JA, Harnois LJ, Weiss T, Scott JB, Trump MW, Mogri I, Cerda F, Alolaiwat AA, Miller AR, Klein AM, Oetting TW, Morris L, Heckart S, Capouch L, He H, Li J. Early versus late awake prone positioning in non-intubated patients with COVID-19. Crit Care. 2021 Sep 17;25(1):340. doi: 10.1186/s13054-021-03761-9.

  PMID: 34535158 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jie Li, PI
• Organization: Rush University

jie_li@rush.edu

3125634643

Study Officials

• Jie Li, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: April 2, 2020
• Primary Completion: January 26, 2021
• Study Completion: February 21, 2021
• Last Updated: March 2, 2022
• Results First Posted: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)