Covid19 Clinical Trial
— RUTIROXOfficial title:
Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia
Verified date | August 2022 |
Source | Germans Trias i Pujol Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | November 7, 2022 |
Est. primary completion date | November 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Germans TiPH | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Germans Trias i Pujol Hospital |
Spain,
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). pii: 2001935. doi: 10.1183/13993003.01935-2020. Print 2020 Oct. — View Citation
Carteaux G, Millán-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. — View Citation
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, Tabbì 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). pii: 2002130. doi: 10.1183/13993003.02130-2020. Print 2020 Nov. — 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
Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 90-day at home recovery | Compare the degree of pre-admission mMRC dyspnea with the degree of mMRC dyspnea 90 days after inclusion in the study. | From the inclusion to 90 days after inclusion in the study. |
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