Acute Respiratory Failure Requiring ReintubationCRHACSNCT01726140
CPAP Reduces Hypoxemia After Cardiac Surgery
A study testing Helmet CPAP and Venturi Mask in people with Acute Respiratory Failure Requiring Reintubation, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure Requiring Reintubation
- What is being tested?
- Helmet CPAP and Venturi Mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Jan 2024
- 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
- patients undergoing cardiac surgery on cardiopulmonary bypass
- PaO2 /FiO2 < 200 after extubation
- extubation time < 24 h.
Who cannot join
- patients < 18 years old
- extracorporeal membrane oxygenation
- severe cardiac dysfunction (FE<25%)
- mechanical ventilation before the intervention
- severe COPD (patients on oxygen therapy, with a FEV1< 50%)
- heart or lung transplantation
- lack of consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, 10126
About this study
Official title: CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial
The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
Read the detailed description
We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
Primary end point: to reduce the rate of re-intubation.
Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.
- Being tested
- Helmet CPAP, Venturi Mask
- Keywords
- intubation, respiratory failure, cardiac surgery
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet CPAPProcedure or surgery
the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be >200, the patient will stop the treatment.
Venturi MaskProcedure or surgery
the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be >200, the patient will stop the treatment.
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Experimental | Helmet CPAP Receives: Procedure: Helmet CPAP |
| CONTROL | Active comparator | Venturi Mask Receives: Procedure: Venturi Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of re-intubation
Measured: at 28 days
Secondary outcomes (6)
incidence of atelectasis
Measured: at 28 days
incidence of pneumonia
Measured: at 28 days
incidence of sepsis
Measured: at 28 days
mortality rate
Measured: at 28 days
the intensive care unit length of stay
Measured: at 28 days
hospital length of stay
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionJul 2023
- Study completionJan 2024
Why it stopped: Reduction of interest and recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure Requiring ReintubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Daniela Pasero, University of Turin, Italy
- Investigators
- Vito Marco VM Ranieri, MD, Study chair, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726140
- Sponsor's protocol ID
- CRHACS CEI-457
- Acronym
- CRHACS
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2012
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pasero D, Costamagna A, Filippini C, Blangetti I, Cattaneo S, Baiocchi M, Balata A, Bottiroli M, Dambruoso P, De Paulis S, Grazioli L, Locatelli A, Lorini FL, Mascotti A, Mondino MG, Paparella D, Salvi L, Tonetti T, Tritapepe L, Ranieri VM. Continuous positive airway pressure to prevent reintubation in patients recovering from cardiac surgery: A multicentre randomised clinical trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):958-965. doi: 10.1097/EJA.0000000000002229. Epub 2025 Jun 27.
PubMed 40574561
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01726140
- Acronym / sponsor ID
- CRHACS / CRHACS CEI-457
- Keywords
- intubation, respiratory failure, cardiac surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reduction of interest and recruitment.
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 14 Nov 2012 (estimated)
- 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 aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
Detailed description
We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
Primary end point: to reduce the rate of re-intubation.
Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Experimental | Procedure: Helmet CPAPHelmet CPAP |
| CONTROL | Active comparator | Procedure: Venturi MaskVenturi Mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing cardiac surgery on cardiopulmonary bypass
- PaO2 /FiO2 < 200 after extubation
- extubation time < 24 h.
Key exclusion criteria (7 listed)
- patients < 18 years old
- extracorporeal membrane oxygenation
- severe cardiac dysfunction (FE<25%)
- mechanical ventilation before the intervention
- severe COPD (patients on oxygen therapy, with a FEV1< 50%)
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 |
|---|---|---|
| Helmet CPAPthe patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be >200, the patient will stop the treatment. | Procedure or surgery | TREATMENT |
| Venturi Maskthe patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be >200, the patient will stop the treatment. | Procedure or surgery | CONTROL |
Primary outcome
rate of re-intubation
Time frame: at 28 days
6 secondary outcomes
incidence of atelectasis
Time frame: at 28 days
incidence of pneumonia
Time frame: at 28 days
incidence of sepsis
Time frame: at 28 days
mortality rate
Time frame: at 28 days
the intensive care unit length of stay
Time frame: at 28 days
hospital length of stay
Time frame: at 28 days
Results and safety
The study was stopped early (reason given: Reduction of interest and recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 40574561Pasero D, Costamagna A, Filippini C, Blangetti I, Cattaneo S, Baiocchi M, Balata A, Bottiroli M, Dambruoso P, De Paulis S, Grazioli L, Locatelli A, Lorini FL, Mascotti A, Mondino MG, Paparella D, Salvi L, Tonetti T, Tritapepe L, Ranieri VM. Continuous positive airway pressure to prevent reintubation in patients recovering from cardiac surgery: A multicentre randomised clinical trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):958-965. doi: 10.1097/EJA.0000000000002229. Epub 2025 Jun 27.
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.
Vito Marco VM Ranieri, MD study chair
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet CPAP and Venturi Mask in people with Acute Respiratory Failure Requiring Reintubation, run by University of Turin, Italy at 1 site in Italy.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Mar 2025. 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 Italy. 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 was stopped early (reason given: Reduction of interest and recruitment.). Results are not available in the source record.
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?
rate of re-intubation (time frame: at 28 days). 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 NCT01726140, which also lists 1 linked publication.
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 17 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.