Respiratory FailureNCT02918786
The Efficacy of the Whisperflow CPAP System Versus Nasal High Flow in Patients at High Risk for Postextubation Failure
A study testing Nasal high-flow and CPAP in people with Respiratory Failure, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the effect of continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Nasal high-flow and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2016to Mar 2017
- 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
- Mechanical ventilation > 48 hours and
- high risk for extubation failure namely , congestive heart failure, ineffective cough and excessive tracheobronchial secretions, more than one failure of a weaning trial, more than one co-morbid condition, patients who had hypercapnia, and upper airway obstruction without immediately required intubation
Who cannot join
- age<18 years
- pregnancy
- tracheostomy
- uncontrolled cardiac ischemia or arrhythmias
- unstable hemodynamic status
- documented swallowing problem
Show all 10Show fewer
- documented cervical spine injury
- Facial anatomical abnormalities interfering with the mask fit
- agitated or uncooperative state
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
Pongdhep Theerawit, MD, 662011619, pongdhep.the@mahidol.ac.th
Yuda Sutherasan, MD, 662011619, sutherasan_yuda@yahoo.com
About this study
Official title: The Efficacy of the Whisperflow CPAP System Versus High Flow Nasal Cannula Oxygen Therapy in Patients at High Risk for Postextubation Failure
The purpose of this study is to compare the effect of continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.
Read the detailed description
Postextubation respiratory failure is not an uncommon condition after discontinuation of mechanical ventilation. Subsequently reintubation and mechanical ventilation for postextubation respiratory failure may lead to increasing of hospital morbidity and mortality and and prolonging intensive care and hospital stay. Several studies have demonstrated the efficacy of non-invasive ventilation to prevent the postextubation failure in patients with high risk for extubation failure.
The variable generator whisper flow system ((Philips Respironics, Murrysville, PA, USA) is the one of widely used continuous positive airway pressure(CPAP) device in UK. This device employs an oxygen-driven venturi to entrain air and generates high fresh gas flow up to 140 liter per minute. The oxygen/air mixture enters the breathing circuit and exits through a threshold resistor namely CPAP valve. Whisperflow is able to provide the flow into the breathing system via oronasal mask which exceeds the peak inspiratory flow rate of the patient and may improve work of breathing as well as gas exchange. In daily clinical practice, the investigators apply this device with humidifier in patients with weaning difficulty and patients who are at risk for postextubation failure.
High-flow nasal oxygen therapy(HFNO) is a device which heated and humidified oxygen is distributed to the nose at high flow rates. With the high flow rate (up to 60 Liter per minute), it generates low level of positive airway pressure. Physiological benefits of HFNO comprises decreasing of the dead space, work of breathing and the low level of positive airway pressure associated with better lung recruitment. Furthermore, the fraction of inspired oxygen can be adjusted and measured by changing the fraction of oxygen in the driving gas.
In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, with low levels of continuous positive airway pressure, nasal high-flow oxygen therapy and CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System with oronasal mask , in critically ill patients who are at risk for postextubation failure. The investigators hypothesize that nasal high-flow is superior to CPAP the in terms of reintubation rate.
- Conditions
- Respiratory Failure
- Being tested
- Nasal high-flow, CPAP
- Keywords
- oxygen therapy, continuous positive airway pressure, extubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high-flowDevice
After extubation, the patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set until maximal level of 60 LPM.
CPAPDevice
After extubation, patients will receive CPAP at 5 cmH2O delivered by the variable generator WhisperFlow System. The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure | Active comparator | After extubation, patients will receive continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System (control) Intervention:Device : CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System for 48 hours Receives: Device: CPAP |
| Nasal high-flow | Active comparator | After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Intervention: Device: Nasal high-flow Receives: Device: Nasal high-flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rate
Number of participants who required reintubation within 48 hours after extubation
Measured: 48 hours
Secondary outcomes (1)
post extubation respiratory failure
Number of participants who required either reintubation or application of Bi-level noninvasive positive airway pressure within 48 hours after extubation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
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 Respiratory FailureStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pongdhep Theerawit, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918786
- Sponsor's protocol ID
- ID 12-58-11
- Status last verified
- Sep 2016
- First submitted
- 16 Aug 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.
PubMed 16276167Glover GW, Fletcher SJ. Assessing the performance of the Whisperflow continuous positive airway pressure generator: a bench study. Br J Anaesth. 2009 Jun;102(6):875-81. doi: 10.1093/bja/aep077. Epub 2009 Apr 19.
PubMed 19380311Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
PubMed 10806150Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
PubMed 19616722
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Whisperflow CPAP System Versus High Flow Nasal Cannula Oxygen Therapy in Patients at High Risk for Postextubation Failure
- ClinicalTrials.gov ID
- NCT02918786
- Acronym / sponsor ID
- ID 12-58-11
- Conditions
- Respiratory Failure
- Keywords
- oxygen therapy, continuous positive airway pressure, extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Sep 2016 (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 purpose of this study is to compare the effect of continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System with high flow nasal cannula oxygen therapy in mechanically ventilated patient who are at risk for postextubation failure.
Detailed description
Postextubation respiratory failure is not an uncommon condition after discontinuation of mechanical ventilation. Subsequently reintubation and mechanical ventilation for postextubation respiratory failure may lead to increasing of hospital morbidity and mortality and and prolonging intensive care and hospital stay. Several studies have demonstrated the efficacy of non-invasive ventilation to prevent the postextubation failure in patients with high risk for extubation failure.
The variable generator whisper flow system ((Philips Respironics, Murrysville, PA, USA) is the one of widely used continuous positive airway pressure(CPAP) device in UK. This device employs an oxygen-driven venturi to entrain air and generates high fresh gas flow up to 140 liter per minute. The oxygen/air mixture enters the breathing circuit and exits through a threshold resistor namely CPAP valve. Whisperflow is able to provide the flow into the breathing system via oronasal mask which exceeds the peak inspiratory flow rate of the patient and may improve work of breathing as well as gas exchange. In daily clinical practice, the investigators apply this device with humidifier in patients with weaning difficulty and patients who are at risk for postextubation failure.
High-flow nasal oxygen therapy(HFNO) is a device which heated and humidified oxygen is distributed to the nose at high flow rates. With the high flow rate (up to 60 Liter per minute), it generates low level of positive airway pressure. Physiological benefits of HFNO comprises decreasing of the dead space, work of breathing and the low level of positive airway pressure associated with better lung recruitment. Furthermore, the fraction of inspired oxygen can be adjusted and measured by changing the fraction of oxygen in the driving gas.
In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, with low levels of continuous positive airway pressure, nasal high-flow oxygen therapy and CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System with oronasal mask , in critically ill patients who are at risk for postextubation failure. The investigators hypothesize that nasal high-flow is superior to CPAP the in terms of reintubation rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure | Active comparator | Device: CPAPAfter extubation, patients will receive continuous positive airway pressure (CPAP) delivered by the variable generator WhisperFlow System (control) Intervention:Device : CPAP of 5 cmH2O delivered by the variable generator WhisperFlow System for 48 hours |
| Nasal high-flow | Active comparator | Device: Nasal high-flowAfter extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Intervention: Device: Nasal high-flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilation > 48 hours and
- high risk for extubation failure namely , congestive heart failure, ineffective cough and excessive tracheobronchial secretions, more than one failure of a weaning trial, more than one co-morbid condition, patients who had hypercapnia, and upper airway obstruction without immediately required intubation
Key exclusion criteria (10 listed)
- age<18 years
- pregnancy
- tracheostomy
- uncontrolled cardiac ischemia or arrhythmias
- unstable hemodynamic status
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 |
|---|---|---|
| Nasal high-flowAfter extubation, the patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set until maximal level of 60 LPM. | Device | Nasal high-flow |
| CPAPAfter extubation, patients will receive CPAP at 5 cmH2O delivered by the variable generator WhisperFlow System. The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. | Device | Continuous positive airway pressure |
Primary outcome
Reintubation rate
Time frame: 48 hours
Number of participants who required reintubation within 48 hours after extubation
1 secondary outcome
post extubation respiratory failure
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Background: PubMed 25003980Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
- Background: PubMed 16276167Nava S, Gregoretti C, Fanfulla F, Squadrone E, Grassi M, Carlucci A, Beltrame F, Navalesi P. Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients. Crit Care Med. 2005 Nov;33(11):2465-70. doi: 10.1097/01.ccm.0000186416.44752.72.
- Background: PubMed 19380311Glover GW, Fletcher SJ. Assessing the performance of the Whisperflow continuous positive airway pressure generator: a bench study. Br J Anaesth. 2009 Jun;102(6):875-81. doi: 10.1093/bja/aep077. Epub 2009 Apr 19.
- Background: PubMed 10806150Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
- Background: PubMed 19616722Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high-flow and CPAP in people with Respiratory Failure, run by Ramathibodi Hospital at 1 site in Thailand.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pongdhep Theerawit, MD (662011619, pongdhep.the@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation rate (time frame: 48 hours). 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 NCT02918786, 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 29 Sep 2016.