Positive End Espiratory Pressure Trial in Coronavirus Disease 19 Treated With Continuous Positive Airway Pressure

NCT05178160 | Completed DMC

• 1 other identifier: N2N-01-COVID 19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Consecutive patients with hypoxemic respiratory failure, CT evidence of bilateral pneumonia and diagnosis of Coronavirus Disease 19 (COVID-19) with molecular nasopharyngeal swab consecutively admitted to the COVID Care Unit of the "Santa Maria delle Grazie" Hospital were enrolled. All the patients with clinical indication for Continuous Positive Airway Pressure (CPAP) were randomized 1:1 into two groups: Group A received a fixed Positive End Expiratory Pressure (PEEP) of 10 centimetre of water (cmH2O), Group B underwent the PEEP trial to identify the optimal PEEP (defined as the highest value that preceded the appearance of the "lung pulse" at lung ultrasound and that determined an increase in PaO2/FiO2 by at least 20%). Primary endpoint was defined as a composite in-hospital mortality+intubation, secondary endpoint was the improvement of PaO2/FiO2. As safety indicator, the incidence of pneumothorax was collected.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

COVID-19; PEEP trial; CPAP; lung ultrasound

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  composite of hospital mortality and need of endotracheal intubation

  From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.

Secondary Outcomes (1)

• Secondary outcome

  From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.

Other Outcomes (1)

• Safety outcome

  From date of randomization until the date of discharge or of endotracheal intubation or death from any cause, whichever came first, assessed up to 90 days.

Study Arms (2)

Group A

ACTIVE COMPARATOR

All the patients undergo to helmet-CPAP setting PEEP at 10 cmH2O and performing a blood gas analysis after 2 hours

Other: PEEP Standard Protocol

Group B

EXPERIMENTAL

All the patients undergo to helmet-CPAP. PEEP was increased from 5 to 7.5 and 10 cmH20 in 30-minute steps during which lung ultrasound and blood gas analyses were repeated. The best PEEP was setted as the PEEP value before the appearance of lung pulse and with a PaO2/FiO2 levels stable or major than 20% in comparison to the basal value

Other: PEEP Standard Protocol

Interventions

PEEP Standard Protocol OTHER

All the patients treated with CPAP receive a PEEP standard of 10 cmH2O with a fixed FiO2

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• age \> 18 years;
• diagnosis of SARS-CoV-2 infection confirmed by means of RT-PCR on specimen from nasopharyngeal swab;
• bilateral interstitial pneumonia at CT scan;
• hypoxemic respiratory failure defined as PaO2/FiO2 \< 200 at blood gas analyses.

You may not qualify if:

• type 2 respiratory failure;
• hemodynamic instability requiring vasopressors and/or inotropes support;
• CT evidence of pneumothorax/pneumomediastinum;
• concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)

Sponsors & Collaborators

• Santa Maria delle Grazie Hospital: lead

Study Sites (1)

COVID CARE UNIT Santa Maria delle Grazie Hospital

Pozzuoli, Naples, 80078, Italy

Location

Related Publications (3)

• Bosso G, Allegorico E, Pagano A, Porta G, Serra C, Minerva V, Mercurio V, Russo T, Altruda C, Arbo P, De Sio C, Dello Vicario F, Numis FG. Lung ultrasound as diagnostic tool for SARS-CoV-2 infection. Intern Emerg Med. 2021 Mar;16(2):471-476. doi: 10.1007/s11739-020-02512-y. Epub 2020 Oct 3.

  PMID: 33011929 RESULT

• Pagano A, Porta G, Bosso G, Allegorico E, Serra C, Dello Vicario F, Minerva V, Russo T, Altruda C, Arbo P, Mercurio V, Numis FG. Non-invasive CPAP in mild and moderate ARDS secondary to SARS-CoV-2. Respir Physiol Neurobiol. 2020 Sep;280:103489. doi: 10.1016/j.resp.2020.103489. Epub 2020 Jul 3.

  PMID: 32629100 RESULT

• Paolini V, Faverio P, Aliberti S, Messinesi G, Foti G, Sibila O, Monzani A, De Giacomi F, Stainer A, Pesci A. Positive end expiratory pressure in acute hypoxemic respiratory failure due to community acquired pneumonia: do we need a personalized approach? PeerJ. 2018 Jan 30;6:e4211. doi: 10.7717/peerj.4211. eCollection 2018.

  PMID: 29404202 RESULT

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Fabio G Numis, MD

  Santa Maria delle Grazie Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 5, 2022
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)