Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia

NCT05094661 | Completed

• 1 other identifier: RUTIROX2021
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the current study is to search predictors of non-invasive respiratory support failure, like high -flow oxygen system (HFO) and pressure systems, Bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP), in patients with acute hypoxemia produced by COVID-19 pneumonia. In the first phase, we will do a retrospective review of the intermediate respiratory care unit activity from March to May 2020 in the target population. In the second phase development an interventional study. At admission all patients will be treated with HFS monitoring clinical variables like respiratory frequency, oxygen saturation, gasometer results and oxygen inspiration fraction. In case of HFO failure, the patients will be randomized to treatment with CPAP or BIPAP. The same clinical variables will be monitoring to analysis their prediction capacity of failure therapy, defined as mortality or need to intubation. The results will be adjusted comorbidity grade, age and initial severity pneumonia. Secondary objectives of study are 90 days mortality, functional recovery at 90 days and to realise a cost-effectiveness valuation of non-invasive respiratory supports in this disease.

Conditions

Noninvasive Ventilation; Covid19; Distress; Respiratory Syndrome, Adult

Keywords

Covid19; Noninvasive ventilation; High flow oxygen

Outcome Measures

Primary Outcomes (2)

• Failure of High Flow Nasal Cannula

  The number of patients with respiratory work or desaturation at the beginning of therapy with high-flow nasal cannulas will be measured. This will be defined with desaturation below 90%, respiratory rate greater than 30 o pO2 below 60 despite receiving a maximum support of 60 liters per minute and with 100% FIO2.

  From the start of High Flow Nasal Cannula support to intubation and invasive ventilation or death at 30 days.

• Failure of Non Invasive Ventilation

  The number of patients with respiratory work or desaturation and who need orotracheal intubation or die will be measured. This will be defined with desaturation below 90%, respiratory rate above 30 o pO2 below 60 despite receiving a maximum pressure support and with 100% FIO2.

  From the start of CPAP or BIPAP to intubation and invasive ventilation or death at 30 days

Secondary Outcomes (1)

• 90-day at home recovery

  From the inclusion to 90 days after inclusion in the study.

Study Arms (2)

Non failure high flow oxygen therapy

NO INTERVENTION

The patient is treated with high flow oxygen system throughout the admission in the intermediate respiratory care unit

Non-invasive ventilation (CPAP/BiPAP)

ACTIVE COMPARATOR

If high flow support fails, the patients will be treated with non-invasive respiratory support.

Procedure: BiPAP; Procedure: CPAP

Interventions

BiPAP PROCEDURE

The patient recives respiratory support with bilevel positive airway pressure system until treatment improves or fails (needs intubation/dies).

Non-invasive ventilation (CPAP/BiPAP)

CPAP PROCEDURE

The patient recives respiratory support with continuous positive airway pressure system until treatment improves or fails (needs intubation/dies).

Non-invasive ventilation (CPAP/BiPAP)

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.
• Severe hypoxemic respiratory failure (partial pressure of arterial oxygen/ fraction of inspired oxygen \< 250 mmHg).
• Confirmed SARS-Cov2 infection.
• Radiological images compatible with pneumonia covid.

You may not qualify if:

• Hypoxemic respiratory failure secondary to a cause other than SARS-Cov2 pneumonia.
• Hypercapnic respiratory failure.
• Patient with criteria of orotracheal intubation at admission.
• Glasgow \< 15
• Haemodynamic instability that needs drugs treatment
• Patients with swallowing problems that conditioned an aspiration pneumonia risk.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Germans TiPH

Barcelona, 08916, Spain

Location

Related Publications (5)

• Aliberti S, Radovanovic D, Billi F, Sotgiu G, Costanzo M, Pilocane T, Saderi L, Gramegna A, Rovellini A, Perotto L, Monzani V, Santus P, Blasi F. Helmet CPAP treatment in patients with COVID-19 pneumonia: a multicentre cohort study. Eur Respir J. 2020 Oct 15;56(4):2001935. doi: 10.1183/13993003.01935-2020. Print 2020 Oct.

  PMID: 32747395 BACKGROUND

• Franco C, Facciolongo N, Tonelli R, Dongilli R, Vianello A, Pisani L, Scala R, Malerba M, Carlucci A, Negri EA, Spoladore G, Arcaro G, Tillio PA, Lastoria C, Schifino G, Tabbi L, Guidelli L, Guaraldi G, Ranieri VM, Clini E, Nava S. Feasibility and clinical impact of out-of-ICU noninvasive respiratory support in patients with COVID-19-related pneumonia. Eur Respir J. 2020 Nov 5;56(5):2002130. doi: 10.1183/13993003.02130-2020. Print 2020 Nov.

  PMID: 32747398 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

• 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 BACKGROUND

• Carteaux G, Millan-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.

  PMID: 26584191 BACKGROUND

MeSH Terms

Conditions

COVID-19; Acute Lung Injury

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; Lung Injury

Study Officials

• Irene IA Aldás Criado

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Respiratory Intermediate Care Unit.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: October 26, 2021
• Study Start: February 18, 2021
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-08

Locations

ES (1)