Respiratory FailureNCT01575353
Nasal High-flow Versus Venturi Mask Oxygen Therapy in the Post-extubation Period
A study testing Venturi mask and Nasal high-flow in people with Respiratory Failure, run by Catholic University of the Sacred Heart at 2 sites in Italy.
Trial summary
The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation 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?
- Venturi mask and Nasal high-flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2010to Nov 2011
- 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 > 24h
- Successful spontaneous breathing trial conducted for a period of 30-120 min.
- PaO2/FiO2 ≤ 300 at the end of the spontaneous breathing trial preceding extubation
Who cannot join
- age<18 years
- pregnancy
- tracheostomy
- need of NIV post-extubation (prophylactic NIV)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
ICU, "Maggiore della Carità", University Hospital
Novara, Novara
ICU "A. Gemelli" University Hospital
Rome, Rome, 00168
About this study
Official title: Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
The aim of the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation
Read the detailed description
Acute respiratory failure is one the most common reason for admission and mechanical ventilation is the most frequent procedure performed in the intensive care unit (ICU). After extubation, oxygen therapy is commonly used to correct residual impairment in oxygenation. Oxygen therapy is usually performed via a Venturi mask allowing to deliver predetermined oxygen concentrations. The face mask is used in the place of nasal cannula in part because patients with acute respiratory failure (ARF) breath preferentially through an open mouth rather than the nose. The mask may, however, reduce comfort and patients with ARF, who are often agitated and poorly cooperative, may displace or self-remove the mask. Given that oxygen delivered to the patient is dry, clinical practice guidelines recommend humidifying the oxygen when above 4 l/min in the ICU setting, because the humidification function of the nasal mucosa can be insufficient at high oxygen flow rates and/or the critically ill patient with ARF often breathes through the mouth. Breathing dry oxygen could provoke dryness of the mouth, nose, throat and respiratory tract, resulting in discomfort and pain that are frequent in the ICU setting. Breathing dry air by the nose may also lead to the alteration of the mucociliary transport system and cause an increase of airway resistance in healthy subjects. However, there are no recommendations concerning the type of humidification device to use.
High-flow oxygen therapy is commonly practiced in the ICU. Recently, a method was described in which high-flow oxygen is delivered through a nasal cannula with an active humidification system that optimizes oxygen administration in patients with ARF (Optiflow, Fisher \& Paykel, New Zealand). This system has several theoretical advantages. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD. Lastly, the use of high humidity levels may prevent damage to the ciliated epithelium of the airways, maintain mucociliary system activity, and facilitate the elimination of secretions. Through these effects, this new device for high-flow oxygen therapy has the potential to be effective and to improve tolerance to the treatment more than conventional systems for oxygen therapy, such as the Venturi mask.
In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, nasal high-flow oxygen therapy and the standard Venturi mask, in critically ill patients who need oxygen in the post-extubation period. The hypothesis is that nasal high-flow is superior to the Venturi mask in terms of oxygenation
- Conditions
- Respiratory Failure
- Being tested
- Venturi mask, Nasal high-flow
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venturi maskDevice
The patients will receive oxygen delivered through a conventional Venturi mask. The FiO2 (color coded) will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.
Nasal high-flowDevice
Also called Optiflow™
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 at 50l/min.
| Study group | Role | What they receive |
|---|---|---|
| Venturi mask | Active comparator | After extubation, patients will receive oxygen therapy through the standard Venturi mask (control) Receives: Device: Venturi mask |
| Nasal high-flow | Active comparator | After extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) Receives: Device: Nasal high-flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation (PaO2/FiO2 ratio)
Arterial blood gases will be collected and the PaO2/FiO2 ratio will be measured 1, 3, 6, 12, 24, 36 and 48 hours after enrollment.
Measured: Up to 48 hours after extubation
Secondary outcomes (1)
Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements
Patient's discomfort, the need and causes for non-invasive ventilation or endotracheal intubation, episodes of oxygen desaturation (defined as SpO2 < 92% or < 88% in hypercapnic patients with chronic obstructive pulmonary disease) and episodes of displacement of the device for oxygen delivery (as estimated by nurses) will be recorded in the 48h study period. Patient's discomfort related to the device used for oxygen therapy and related to the degree of humidification will be assessed by using a numerical rating scale from 0 (no discomfort) to 10 (maximum imaginable discomfort). Patients will be asked to rate their discomfort with the used device and discomfort symptoms will be determined for the dryness of the delivered oxygen (dryness of the mouth, throat, nose, difficulty to swallow and throat pain).
Measured: 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionNov 2011
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Maurizio MAGGIORE, Catholic University of the Sacred Heart
- Investigators
- Salvatore Maurizio Maggiore, MD, PhD, Principal investigator, Catholic University of the Sacred HeartMassimo Antonelli, MD, Study director, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575353
- Sponsor's protocol ID
- 1399/10
- Status last verified
- Feb 2014
- First submitted
- 13 Dec 2010
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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 25003980
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High-flow Oxygen Therapy vs Standard Oxygen Therapy Via Venturi Mask in the Post-extubation Period
- ClinicalTrials.gov ID
- NCT01575353
- Acronym / sponsor ID
- 1399/10
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Apr 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 the study is to compare two devices for oxygen therapy, nasal high-flow and Venturi mask, in critically ill patients in the post-extubation period. The hypothesis is that nasal high-flow may be superior to the Venturi mask in terms of oxygenation
Detailed description
Acute respiratory failure is one the most common reason for admission and mechanical ventilation is the most frequent procedure performed in the intensive care unit (ICU). After extubation, oxygen therapy is commonly used to correct residual impairment in oxygenation. Oxygen therapy is usually performed via a Venturi mask allowing to deliver predetermined oxygen concentrations. The face mask is used in the place of nasal cannula in part because patients with acute respiratory failure (ARF) breath preferentially through an open mouth rather than the nose. The mask may, however, reduce comfort and patients with ARF, who are often agitated and poorly cooperative, may displace or self-remove the mask. Given that oxygen delivered to the patient is dry, clinical practice guidelines recommend humidifying the oxygen when above 4 l/min in the ICU setting, because the humidification function of the nasal mucosa can be insufficient at high oxygen flow rates and/or the critically ill patient with ARF often breathes through the mouth. Breathing dry oxygen could provoke dryness of the mouth, nose, throat and respiratory tract, resulting in discomfort and pain that are frequent in the ICU setting. Breathing dry air by the nose may also lead to the alteration of the mucociliary transport system and cause an increase of airway resistance in healthy subjects. However, there are no recommendations concerning the type of humidification device to use.
High-flow oxygen therapy is commonly practiced in the ICU. Recently, a method was described in which high-flow oxygen is delivered through a nasal cannula with an active humidification system that optimizes oxygen administration in patients with ARF (Optiflow, Fisher \& Paykel, New Zealand). This system has several theoretical advantages. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD. Lastly, the use of high humidity levels may prevent damage to the ciliated epithelium of the airways, maintain mucociliary system activity, and facilitate the elimination of secretions. Through these effects, this new device for high-flow oxygen therapy has the potential to be effective and to improve tolerance to the treatment more than conventional systems for oxygen therapy, such as the Venturi mask.
In the present randomized, controlled trial, the investigators will compare two devices for oxygen therapy, nasal high-flow oxygen therapy and the standard Venturi mask, in critically ill patients who need oxygen in the post-extubation period. The hypothesis is that nasal high-flow is superior to the Venturi mask in terms of oxygenation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venturi mask | Active comparator | Device: Venturi maskAfter extubation, patients will receive oxygen therapy through the standard Venturi mask (control) |
| Nasal high-flow | Active comparator | Device: Nasal high-flowAfter extubation, patients will receive oxygen therapy through the nasal high-flow (intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation > 24h
- Successful spontaneous breathing trial conducted for a period of 30-120 min.
- PaO2/FiO2 ≤ 300 at the end of the spontaneous breathing trial preceding extubation
Key exclusion criteria (4 listed)
- age<18 years
- pregnancy
- tracheostomy
- need of NIV post-extubation (prophylactic NIV)
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 |
|---|---|---|
| Venturi maskThe patients will receive oxygen delivered through a conventional Venturi mask. The FiO2 (color coded) 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 | Venturi mask |
| Nasal high-flowAlso: Optiflow™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 at 50l/min. | Device | Nasal high-flow |
Primary outcome
Oxygenation (PaO2/FiO2 ratio)
Time frame: Up to 48 hours after extubation
Arterial blood gases will be collected and the PaO2/FiO2 ratio will be measured 1, 3, 6, 12, 24, 36 and 48 hours after enrollment.
1 secondary outcome
Patient's discomfort, need for non-invasive ventilation, endotracheal intubation, oxygen desaturations, interface displacements
Time frame: 48 hours after enrollment
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 28 Feb 2014.
- Derived from this study: 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.
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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.
Salvatore Maurizio Maggiore, MD, PhD principal investigator
Catholic University of the Sacred Heart
Massimo Antonelli, MD study director
Catholic University of the Sacred Heart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venturi mask and Nasal high-flow in people with Respiratory Failure, run by Catholic University of the Sacred Heart at 2 sites 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 4 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Oxygenation (PaO2/FiO2 ratio) (time frame: Up to 48 hours after extubation). 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 NCT01575353, 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 28 Feb 2014.