Noninvasive VentilationRUTIROXNCT05094661
Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia
A study testing BiPAP and CPAP in people with Noninvasive Ventilation and Covid19, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Covid19, Distress; Respiratory Syndrome, Adult
- What is being tested?
- BiPAP and CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2021to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The purpose of the study
Pneumonia caused by the SARS Cov-2 coronavirus is a viral infectious disease that is characterized in some cases by the rapid and progressive respiratory failure of the respiratory system, being the most serious affectation and the one that marks the prognosis. Non-invasive breathing supports are therapies that help you breathe in severe respiratory failure. Therefore, monitoring of respiratory exhaustion should be carried out in all patients with SARS Cov-2 pneumonia. Within this follow-up, prognostic factors could be identified that help to assess with what probability the treatment with these supports may or may not be successful.
We will carry out a prospective, descriptive study at this center in order to assess respiratory clinical variables by telemetry recording and blood tests during follow-up.
To do this, we will carry out, during the follow-up of patients already diagnosed, or with a new diagnosis of SARS Cov-2 pneumonia and respiratory failure, who require non-invasive support therapy, an analysis on the first day of initiation of therapy, at 48 hours and at the end of this therapy, we will also continuously monitor vital signs while these therapies are used. We will compare the values obtained from patients who only require therapy with high-flow nasal cannulas and from patients who are not sufficient for this treatment and need non-invasive mechanical ventilation.
Participants in this study who do not have sufficient respiratory support with high-flow cannula therapy and feel exhausted, will be switched to non-invasive mechanical ventilation. Each patient will be randomly assigned to one of two possible settings: setting A (continuous pressure mechanical ventilation) or setting B (intermittent pressure mechanical ventilation). This decision is made because to date there are no scientifically proven differences in which configuration is best for the treatment of this disease. The data on the success of the therapies will be compared, understanding as failure the need for orotracheal intubation to perform invasive mechanical ventilation or death.
This research study has been approved by the Research Ethics Committee of the Germans Trias i Pujol University Hospital.
Study Procedures and Possible Risks and Discomforts Vital signs will be recorded during the time that non-invasive respiratory support therapy is performed continuously for the assessment of respiratory status. This does not pose any additional risk, since it is a non-invasive procedure and without exposure to ionizing radiation.
Between 3 and 5 tests will be carried out during the study, which are the same as those carried out in the usual clinical practice of this disease. They pose risks of pain due to puncture and extravasation of a blood vessel.
Participation in this study would not produce any discomfort except those derived from the non-invasive respiratory support therapies themselves. These are: epistaxis, runny nose, excessive noise in the treatment with high-flow cannulas and skin ulcers in the case of non-invasive mechanical ventilation. It does not imply an added risk to that of normal clinical practice for health since an additional intervention will not be carried out.
The information regarding your personal data (initials and medical record number) will be coded, a non-consecutive alphanumeric code will be assigned, which will be called the patient study code. This will only be known to the principal investigators, who will save this data using a password-protected Microsoft Excel file.
The clinical information collected for the study associated with your patient code will be stored in a Microsoft Excel type computer file located at the research center. The REDCAP form will be used for data collection. To access it, you will need a second password different from the first one. These data can only be re-identified by the study's principal investigators or by collaborators authorized by them. They will be used exclusively for the purposes specified here.
Voluntary participation and withdrawal You can freely decide whether or not you want to take part in this study, participation is completely voluntary. If you decide to participate, you still have the possibility to withdraw at any time, without having to give explanations, and without any penalty or negative consequences for you. If you change your mind regarding your samples or your data, you have the right to request their destruction or destruction. anonymization, through your doctor / researcher. However, you should know that the data obtained in the analyzes carried out up to that moment may be used for the purposes requested and may be kept in compliance with the corresponding legal obligations.
Participation in this study is not incompatible with participation in other clinical studies or trials.
Possible benefits No direct benefit is expected from your participation in the study. However, the information gained from this research project can contribute to medical advancement and could help other patients in the future. You will not receive any economic benefit for the transfer of the data provided, nor will you have rights over possible commercial benefits of the discoveries that may be achieved as a result of the research carried out.
Data protection and confidentiality
All information about your results will be treated strictly confidential. Your personal data will be identified by a code, so that it does not include information that can identify you, and only the research team will be able to relate that data to you. These data will be protected by password. These coded clinical data will be the ones that will be statistically analyzed to search for scientific findings that answer the questions proposed in this study. The analysis of this data will be carried out by the external company BUTLER SCIENTIFICS using Auto-discovery technology. This has signed a confidentiality and data treatment contract with the promoting center and the study researchers. This company will receive the data by means of a file with a password via email from the promoter center. BUTLER SCIENTIFCS in no case will know identifying data of the study participants. You may only make one research use for this study. You will not be able to trade or use the data for other purposes.
The Germans Trias i Pujol University Hospital - ICS Metropolitana Nord, as promoter and center where the study is carried out, assumes responsibility for data protection. Your personal data will be protected in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD, having the right to access, rectify or cancel your data, and can limit the processing of data that are incorrect, request a copy or have the data that you have provided to a third party be transferred to To exercise your rights, contact the study's main researchers or collaborators whose data is specified at the end of this document. You can also contact the Data Protection Department of TIC Salut dpd@ticsalutsocial.cat . You also have the right to to contact the Data Protection Agency if you are not satisfied.
If the results of the study were subject to publication in scientific journals, personal data of the participants in this research will not be provided at any time.
Information on results In the event that you request it, at the end of the study and in accordance with article 27 of Law 14/2007 on Biomedical Research, information on the results of this research work may be provided to you
- Being tested
- BiPAP, CPAP
- Keywords
- Covid19, Noninvasive ventilation, High flow oxygen
- Medical subject headings
- COVID-19, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAPProcedure or surgery
The patient recives respiratory support with bilevel positive airway pressure system until treatment improves or fails (needs intubation/dies).
CPAPProcedure or surgery
The patient recives respiratory support with continuous positive airway pressure system until treatment improves or fails (needs intubation/dies).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: BiPAP; Procedure: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Compare the degree of pre-admission mMRC dyspnea with the degree of mMRC dyspnea 90 days after inclusion in the study.
Measured: From the inclusion to 90 days after inclusion in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start18 Feb 2021
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Aldas, Germans Trias i Pujol Hospital
- Investigators
- Irene IA Aldás Criado, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094661
- Sponsor's protocol ID
- RUTIROX2021
- Acronym
- RUTIROX
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32747395Franco 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.
PubMed 32747398Frat 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.
PubMed 25981908Roca 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.
PubMed 30576221Carteaux 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.
PubMed 26584191
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05094661
- Acronym / sponsor ID
- RUTIROX / RUTIROX2021
- Keywords
- Covid19, Noninvasive ventilation, High flow oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study
Pneumonia caused by the SARS Cov-2 coronavirus is a viral infectious disease that is characterized in some cases by the rapid and progressive respiratory failure of the respiratory system, being the most serious affectation and the one that marks the prognosis. Non-invasive breathing supports are therapies that help you breathe in severe respiratory failure. Therefore, monitoring of respiratory exhaustion should be carried out in all patients with SARS Cov-2 pneumonia. Within this follow-up, prognostic factors could be identified that help to assess with what probability the treatment with these supports may or may not be successful.
We will carry out a prospective, descriptive study at this center in order to assess respiratory clinical variables by telemetry recording and blood tests during follow-up.
To do this, we will carry out, during the follow-up of patients already diagnosed, or with a new diagnosis of SARS Cov-2 pneumonia and respiratory failure, who require non-invasive support therapy, an analysis on the first day of initiation of therapy, at 48 hours and at the end of this therapy, we will also continuously monitor vital signs while these therapies are used. We will compare the values obtained from patients who only require therapy with high-flow nasal cannulas and from patients who are not sufficient for this treatment and need non-invasive mechanical ventilation.
Participants in this study who do not have sufficient respiratory support with high-flow cannula therapy and feel exhausted, will be switched to non-invasive mechanical ventilation. Each patient will be randomly assigned to one of two possible settings: setting A (continuous pressure mechanical ventilation) or setting B (intermittent pressure mechanical ventilation). This decision is made because to date there are no scientifically proven differences in which configuration is best for the treatment of this disease. The data on the success of the therapies will be compared, understanding as failure the need for orotracheal intubation to perform invasive mechanical ventilation or death.
This research study has been approved by the Research Ethics Committee of the Germans Trias i Pujol University Hospital.
Study Procedures and Possible Risks and Discomforts Vital signs will be recorded during the time that non-invasive respiratory support therapy is performed continuously for the assessment of respiratory status. This does not pose any additional risk, since it is a non-invasive procedure and without exposure to ionizing radiation.
Between 3 and 5 tests will be carried out during the study, which are the same as those carried out in the usual clinical practice of this disease. They pose risks of pain due to puncture and extravasation of a blood vessel.
Participation in this study would not produce any discomfort except those derived from the non-invasive respiratory support therapies themselves. These are: epistaxis, runny nose, excessive noise in the treatment with high-flow cannulas and skin ulcers in the case of non-invasive mechanical ventilation. It does not imply an added risk to that of normal clinical practice for health since an additional intervention will not be carried out.
The information regarding your personal data (initials and medical record number) will be coded, a non-consecutive alphanumeric code will be assigned, which will be called the patient study code. This will only be known to the principal investigators, who will save this data using a password-protected Microsoft Excel file.
The clinical information collected for the study associated with your patient code will be stored in a Microsoft Excel type computer file located at the research center. The REDCAP form will be used for data collection. To access it, you will need a second password different from the first one. These data can only be re-identified by the study's principal investigators or by collaborators authorized by them. They will be used exclusively for the purposes specified here.
Voluntary participation and withdrawal You can freely decide whether or not you want to take part in this study, participation is completely voluntary. If you decide to participate, you still have the possibility to withdraw at any time, without having to give explanations, and without any penalty or negative consequences for you. If you change your mind regarding your samples or your data, you have the right to request their destruction or destruction. anonymization, through your doctor / researcher. However, you should know that the data obtained in the analyzes carried out up to that moment may be used for the purposes requested and may be kept in compliance with the corresponding legal obligations.
Participation in this study is not incompatible with participation in other clinical studies or trials.
Possible benefits No direct benefit is expected from your participation in the study. However, the information gained from this research project can contribute to medical advancement and could help other patients in the future. You will not receive any economic benefit for the transfer of the data provided, nor will you have rights over possible commercial benefits of the discoveries that may be achieved as a result of the research carried out.
Data protection and confidentiality
All information about your results will be treated strictly confidential. Your personal data will be identified by a code, so that it does not include information that can identify you, and only the research team will be able to relate that data to you. These data will be protected by password. These coded clinical data will be the ones that will be statistically analyzed to search for scientific findings that answer the questions proposed in this study. The analysis of this data will be carried out by the external company BUTLER SCIENTIFICS using Auto-discovery technology. This has signed a confidentiality and data treatment contract with the promoting center and the study researchers. This company will receive the data by means of a file with a password via email from the promoter center. BUTLER SCIENTIFCS in no case will know identifying data of the study participants. You may only make one research use for this study. You will not be able to trade or use the data for other purposes.
The Germans Trias i Pujol University Hospital - ICS Metropolitana Nord, as promoter and center where the study is carried out, assumes responsibility for data protection. Your personal data will be protected in accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD, having the right to access, rectify or cancel your data, and can limit the processing of data that are incorrect, request a copy or have the data that you have provided to a third party be transferred to To exercise your rights, contact the study's main researchers or collaborators whose data is specified at the end of this document. You can also contact the Data Protection Department of TIC Salut dpd@ticsalutsocial.cat . You also have the right to to contact the Data Protection Agency if you are not satisfied.
If the results of the study were subject to publication in scientific journals, personal data of the participants in this research will not be provided at any time.
Information on results In the event that you request it, at the end of the study and in accordance with article 27 of Law 14/2007 on Biomedical Research, information on the results of this research work may be provided to you
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: BiPAP, Procedure: CPAPIf high flow support fails, the patients will be treated with non-invasive respiratory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiPAPThe patient recives respiratory support with bilevel positive airway pressure system until treatment improves or fails (needs intubation/dies). | Procedure or surgery | Non-invasive ventilation (CPAP/BiPAP) |
| CPAPThe patient recives respiratory support with continuous positive airway pressure system until treatment improves or fails (needs intubation/dies). | Procedure or surgery | Non-invasive ventilation (CPAP/BiPAP) |
Primary outcome
Failure of High Flow Nasal Cannula
Time frame: From the start of High Flow Nasal Cannula support to intubation and invasive ventilation or death at 30 days.
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.
Failure of Non Invasive Ventilation
Time frame: From the start of CPAP or BIPAP to intubation and invasive ventilation or death at 30 days
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.
1 secondary outcome
90-day at home recovery
Time frame: From the inclusion to 90 days after inclusion in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 32747395Aliberti 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.
- Background: PubMed 32747398Franco 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.
- Background: PubMed 25981908Frat 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.
- Background: PubMed 30576221Roca 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.
- Background: PubMed 26584191Carteaux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene IA Aldás Criado principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP and CPAP in people with Noninvasive Ventilation and Covid19, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of High Flow Nasal Cannula (time frame: From the start of High Flow Nasal Cannula support to intubation and invasive ventilation or death at 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094661, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.