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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325906
• Other study ID #: COVID-19-HFNC+PP
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: February 21, 2021

Study information

• Verified date: February 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 21, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

1. 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);

2. Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);

3. unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);

4. unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.

5. chest trauma or any contraindication for PP

6. pneumothorax

7. age < 18 years

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Corona Virus Infection
• Coronavirus Infections
• High Flow Nasal Cannula
• Prone Positioning
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• high flow nasal cannula (HFNC)
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.

Procedure:
• Prone positioning (PP)
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%.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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 — View Citation

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, Béduneau G, Delétage-Métreau 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. — View Citation

Guérin 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. — View Citation

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-intub — View Citation

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. — View Citation

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. Review. — View Citation

Pavlov I, He H, McNicholas B, Perez Y, Tavernier E, Trump MW, Jackson JA, Zhang W, Rubin DS, Spiegel T, Hung A, Estrada MÁI, 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. 2021 Jul 7. pii: respcare.09191. doi: 10.4187/respcare.09191. [Epub ahead of print] Review. — View Citation

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. [Epub ahead of print] Chinese. — View Citation

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. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure (Intubation or Death)	the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment	28 days
Primary	Number of Participants With Intubation	intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment	28 days
Primary	Mortality	mortality of HFNC/HFNC+PP support within 28 days of study enrollment	28 days
Secondary	Number of Participants With Adverse Events	adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest	28 days of study enrollment