Acute Respiratory FailureOPTINIVNCT01925534
Pilot Study of High-flow Humidified Nasal Oxygen During Breaks From Noninvasive Ventilation
A study testing High-flow humidified nasal oxygen delivery system and Standard oxygen therapy in people with Acute Respiratory Failure and Treatment With Noninvasive Positive Pressure Ventilation, run by Tufts Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Treatment With Noninvasive Positive Pressure Ventilation
- What is being tested?
- High-flow humidified nasal oxygen delivery system and Standard oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.
- Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH <7.35 and arterial CO2 > 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or
- Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio < 300 and respiratory rate ≥ 24.
- Anticipated duration on NIV of at least 24 hrs
Who cannot join
- Usual contraindications to NIV
- Respiratory arrest
- Unable to fit mask
- Medically unstable or multiple organ failure or unstable coronary disease
- Agitated or uncooperative
- Unable to protect airways
Show all 19Show fewer
- Swallowing difficulties
- Excessive secretions not managed by clearance techniques
- Recent upper airway or gastro-intestinal surgery
- Facial deformity or previous head and neck surgery
- Undrained pneumothorax
- NIV failure within first 2 hours (either intolerance or requirement for intubation)
- Managed for greater than 48 hours on NIV prior to randomization
- Disorientation, confusion, unable to rate comfort or dyspnea
- Expected to require NIV for fewer than 24 hrs from the time of enrollment
- Patient previously in study
- Patients on CPAP nighttime only due to OSA
- Withdrawal/Termination criteria:
- Patients will be withdrawn from the study when NIV fails and/or the patient is intubated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intensive Care Unit and Intermediate Care Unit, Tufts Medical Center
Boston, Massachusetts, 02111
Intensive Care Unit, Winchester Hospital
Winchester, Massachusetts, 01890
About this study
Official title: Pilot Study of Optiflow as a NIV Rest Therapy
The purpose of this study is to assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. The investigators anticipate that the Optiflow will provide oxygen more effectively, be more comfortable and permit longer breaks off NIV, shortening the total duration of NIV.
Read the detailed description
Background: Noninvasive ventilation (NIV) provides respiratory support to many patients affected by acute respiratory failure. This treatment, compared to invasive mechanical ventilation, allows patients to take intermittent breaks during which oxygen therapy is provided through a nasal cannula or mask. During these breaks, the lack of ventilator support may predispose to respiratory distress, retention of CO2 and oxygen desaturation. Optiflow is a nasal humidified (37◦C, 44mg/L H2O) high-flow (up to 60 L/min) therapy which can provide greater support than standard oxygen therapy during the breaks from NIV.
Aim of the study is to evaluate Optiflow as an alternative to standard oxygen therapy during breaks from NIV in patients with acute respiratory failure. The investigators hypothesize tha Optiflow will reduce the total length of stay on NIV, and increase the comfort and length of the breaks. Also, the investigators anticipate that it will reduce respiratory rate, accessory muscle use and dyspnea score compared to standard oxygen therapy.
Experimental design Prospective open-label, parallel, randomized (1:1) controlled study, with a target enrollment of 70.
Study procedures Enrolled patients receiving NIV will be randomized into two arms; a treatment group which will receive Optiflow during breaks and a control arm which will receive standard oxygen therapy during breaks. In both cases, FiO2 will be titrated to maintain oxygen saturation above 90%. The necessity of breaks will be determined together with the patients (talk, eat, medication, communicate with family, inability to tolerate the interface), and the need to resume NIV will be based on clinical data, such as dyspnea, respiratory rate, heart rate, blood pressure, oxygen saturation, transcutaneous carbon dioxide (CO2) and patients' desire.
Recorded data: The investigators will record demographic baseline data; Glasgow Coma Scale, respiratory and heart rate, blood pressure, dyspnea score, accessory muscle use, and comfort score at randomization, at the end of each NIV session and NIV break; the length of each NIV session and break; the medications administered and all the arterial blood gases (ABG) on a daily basis. Moreover the investigators will record the NIV parameters and inspired oxygen fraction (FiO2) at each session and break.
Risks: The investigators don't anticipate any significant risks related to the study procedures and equipment. Some patients may not tolerate the Optiflow and some patients may fail NIV and require intubation.
- Being tested
- High-flow humidified nasal oxygen delivery system, Standard oxygen therapy
- Keywords
- Optiflow, Humidified high-flow oxygen therapy, Noninvasive ventilation, Acute respiratory failure, Standard oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow humidified nasal oxygen delivery systemDevice
Also called Optiflow
During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
Standard oxygen therapyDevice
During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow | Experimental | High-flow humidified nasal oxygen delivery system Receives: Device: High-flow humidified nasal oxygen delivery system |
| Oxygen therapy | Active comparator | Standard oxygen therapy Receives: Device: Standard oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay on Noninvasive Ventilation (NIV)
The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.
Measured: Day 1-7
Secondary outcomes (6)
Length of Breaks From NIV
This is done by having nursing staff note times of break start (off NIV) to start of next session of NIV in minutes. Subgroup analysis was performed to assess differences between hypercapnic and hypoxemic patients, not observed in terms of time spent on or off NIV.
Measured: Day 4-10
Assessment of Respiratory Rate During Break
Evaluation of respiratory rate. This was counted for a minute at bedside at start and finish of break.
Measured: day 1-4
Patients' Comfort
Using a visual analogue scale (VAS). Patients rate how comfortable they felt on a 1 to 10 scale with 10 being most comfortable and 1 being the least comfortable.
Measured: Day 2-4
Oxygen Saturation During Breaks
Using pulse oximetry (SpO2) at beginning and end of breaks
Measured: day 1-4
Need for Intubation
Count of participants who underwent endotracheal intubation
Measured: Days 2-10
Ease of Eating
difficulty eating using patient rating on a visual analog scale of 0 for easy eating and 4 for difficult eating. Results tabulated as number of patients finding it easy to eat (Score of 0-1)
Measured: Day 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Nicholas S Hill, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925534
- Sponsor's protocol ID
- FPH-OF13-01
- Other IDs
- IRB-10967
- Acronym
- OPTINIV
- Status last verified
- Jun 2024
- First submitted
- 31 Jul 2013
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ricard JD, Boyer A. Humidification during oxygen therapy and non-invasive ventilation: do we need some and how much? Intensive Care Med. 2009 Jun;35(6):963-5. doi: 10.1007/s00134-009-1457-9. Epub 2009 Mar 18. No abstract available.
PubMed 19294364El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.
PubMed 23013907Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PubMed 21946925Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
PubMed 20406507Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
PubMed 21496369Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
PubMed 21908497Parke RL, McGuinness SP, Eccleston ML. A preliminary randomized controlled trial to assess effectiveness of nasal high-flow oxygen in intensive care patients. Respir Care. 2011 Mar;56(3):265-70. doi: 10.4187/respcare.00801. Epub 2011 Jan 21.
PubMed 21255498Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.
PubMed 23128844
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Optiflow as a NIV Rest Therapy
- ClinicalTrials.gov ID
- NCT01925534
- Acronym / sponsor ID
- OPTINIV / FPH-OF13-01
- Keywords
- Optiflow, Humidified high-flow oxygen therapy, Noninvasive ventilation, Acute respiratory failure, Standard oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Posted 3 Jul 2024
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 assess whether Optiflow, a high-flow humidified oxygen delivery system, is superior to standard oxygen therapy during breaks off noninvasive ventilation in patients affected by acute respiratory failure and in respiratory distress. The investigators anticipate that the Optiflow will provide oxygen more effectively, be more comfortable and permit longer breaks off NIV, shortening the total duration of NIV.
Detailed description
Background: Noninvasive ventilation (NIV) provides respiratory support to many patients affected by acute respiratory failure. This treatment, compared to invasive mechanical ventilation, allows patients to take intermittent breaks during which oxygen therapy is provided through a nasal cannula or mask. During these breaks, the lack of ventilator support may predispose to respiratory distress, retention of CO2 and oxygen desaturation. Optiflow is a nasal humidified (37◦C, 44mg/L H2O) high-flow (up to 60 L/min) therapy which can provide greater support than standard oxygen therapy during the breaks from NIV.
Aim of the study is to evaluate Optiflow as an alternative to standard oxygen therapy during breaks from NIV in patients with acute respiratory failure. The investigators hypothesize tha Optiflow will reduce the total length of stay on NIV, and increase the comfort and length of the breaks. Also, the investigators anticipate that it will reduce respiratory rate, accessory muscle use and dyspnea score compared to standard oxygen therapy.
Experimental design Prospective open-label, parallel, randomized (1:1) controlled study, with a target enrollment of 70.
Study procedures Enrolled patients receiving NIV will be randomized into two arms; a treatment group which will receive Optiflow during breaks and a control arm which will receive standard oxygen therapy during breaks. In both cases, FiO2 will be titrated to maintain oxygen saturation above 90%. The necessity of breaks will be determined together with the patients (talk, eat, medication, communicate with family, inability to tolerate the interface), and the need to resume NIV will be based on clinical data, such as dyspnea, respiratory rate, heart rate, blood pressure, oxygen saturation, transcutaneous carbon dioxide (CO2) and patients' desire.
Recorded data: The investigators will record demographic baseline data; Glasgow Coma Scale, respiratory and heart rate, blood pressure, dyspnea score, accessory muscle use, and comfort score at randomization, at the end of each NIV session and NIV break; the length of each NIV session and break; the medications administered and all the arterial blood gases (ABG) on a daily basis. Moreover the investigators will record the NIV parameters and inspired oxygen fraction (FiO2) at each session and break.
Risks: The investigators don't anticipate any significant risks related to the study procedures and equipment. Some patients may not tolerate the Optiflow and some patients may fail NIV and require intubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow | Experimental | Device: High-flow humidified nasal oxygen delivery systemHigh-flow humidified nasal oxygen delivery system |
| Oxygen therapy | Active comparator | Device: Standard oxygen therapyStandard oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 18 or more years of age treated with Bipap or CPAP as per hospital protocol, with an underlying clinical diagnosis of acute respiratory failure.
- Patients that, prior to administration of NIV, had persistent respiratory acidosis with a pH <7.35 and arterial CO2 > 45 mmHg despite controlled oxygen therapy and standard medical management i.e. bronchodilators, corticosteroids and antibiotics, or
- Patients with hypoxemic respiratory failure with a PaO2/FiO2 ratio < 300 and respiratory rate ≥ 24.
- Anticipated duration on NIV of at least 24 hrs
Key exclusion criteria (19 listed)
- Usual contraindications to NIV
- Respiratory arrest
- Unable to fit mask
- Medically unstable or multiple organ failure or unstable coronary disease
- Agitated or uncooperative
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 |
|---|---|---|
| High-flow humidified nasal oxygen delivery systemAlso: OptiflowDuring breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%. | Device | Optiflow |
| Standard oxygen therapyDuring breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%. | Device | Oxygen therapy |
Primary outcome
Length of Stay on Noninvasive Ventilation (NIV)
Time frame: Day 1-7
The investigator will measure the total time on NIV in day(s), hours and minutes. This is done by having nursing staff note times of NIV start to finish of each session of NIV. They were added to get cumulative time.
6 secondary outcomes
Length of Breaks From NIV
Time frame: Day 4-10
Assessment of Respiratory Rate During Break
Time frame: day 1-4
Patients' Comfort
Time frame: Day 2-4
Oxygen Saturation During Breaks
Time frame: day 1-4
Need for Intubation
Time frame: Days 2-10
Ease of Eating
Time frame: Day 1-4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19294364Ricard JD, Boyer A. Humidification during oxygen therapy and non-invasive ventilation: do we need some and how much? Intensive Care Med. 2009 Jun;35(6):963-5. doi: 10.1007/s00134-009-1457-9. Epub 2009 Mar 18. No abstract available.
- Background: PubMed 23013907El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.
- Background: PubMed 21946925Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
- Background: PubMed 20406507Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
- Background: PubMed 21496369Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
- Background: PubMed 21908497Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
- Background: PubMed 21255498Parke RL, McGuinness SP, Eccleston ML. A preliminary randomized controlled trial to assess effectiveness of nasal high-flow oxygen in intensive care patients. Respir Care. 2011 Mar;56(3):265-70. doi: 10.4187/respcare.00801. Epub 2011 Jan 21.
- Background: PubMed 23128844Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.
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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.
Nicholas S Hill, MD principal investigator
Tufts Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow humidified nasal oxygen delivery system and Standard oxygen therapy in people with Acute Respiratory Failure and Treatment With Noninvasive Positive Pressure Ventilation, run by Tufts Medical Center at 2 sites in United States.
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 19 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 3 Jul 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay on Noninvasive Ventilation (NIV) (time frame: Day 1-7). 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 NCT01925534, which also lists 8 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 3 Jul 2024.