Acute Respiratory FailureNCT03721419
High-Flow Oxygen Therapy Following Tracheostomy
A study testing High Flow High Humidity device and Low Flow High Humidity device in people with Acute Respiratory Failure, run by Barnes-Jewish Hospital at 1 site in United States.
Trial summary
Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High Flow High Humidity device and Low Flow High Humidity device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 7 Apr 2020
- 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
- Mechanically ventilated patients who receive tracheostomy
Who cannot join
- Non-English speaking and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Flow (LF) Oxygen Versus Heated Humidified High-Flow (HF) Therapy Following Tracheostomy
Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.
Read the detailed description
Many patients with Respiratory Failure undergo tracheostomy due to difficulty weaning from mechanical ventilation. A component of weaning a patient with tracheostomy usually involves the administration of oxygen via High Humidity device. There are two major ways of administering oxygen via High Humidity to patients. They include low flow high humidity; delivered at less than or equal to 10LPM or high-flow humidity, delivered at greater than 10LPM. There is not a currently accepted standard of practice for how to administer oxygen high humidity to patients who receive a tracheostomy due to respiratory failure. Both Low and High Flow high humidity devices are used routinely by health care facilities nationwide. Therefore, the investigators plan to perform a crossover study in both a medicine and surgical Intensive Care Unit to determine which type of oxygen High Humidity therapy should be preferentially utilized. Patients in one Intensive Care Unit will start off with Low Flow high humidity while the alternate unit will start with Hi Flow high humidity. After one half of the required sample size is accrued the investigators will cross over the two ICUs to the alternate type of oxygen High Humidity device. No other respiratory practices will change during the conduct of this trial.
- Conditions
- Acute Respiratory Failure
- Being tested
- High Flow High Humidity device, Low Flow High Humidity device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow High Humidity deviceDevice
Also called Airvo high flow device
High Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2)
Low Flow High Humidity deviceDevice
Also called High Humidity Trach Collar
Standard high humidity trach collar utilizing venturi device bleed in
| Study group | Role | What they receive |
|---|---|---|
| High Flow High Humidity device | Experimental | High Flow High Humidity device arm subjects will be placed on a High Flow Airvo device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. This device has its own flow generator built in. Receives: Device: High Flow High Humidity device |
| Low Flow High Humidity Device | Active comparator | Low Flow High Humidity device arm patients will be placed on a Low Flow device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. Receives: Device: Low Flow High Humidity device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Mechanical Ventilation (MV)
Time in days from initiation of MV until discontinuance of MV
Measured: an average of 1 year
Secondary outcomes (2)
Days of ICU Stay
The number of days the subject is in the ICU
Measured: an average of 1 year
Days of hospital stay
Time in days from admission to hospital until discharge from hospital
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start17 May 2018
- Primary completion30 Mar 2020
- Study completion7 Apr 2020
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Crossover study between 2 medical ICUs and 1 Surgical ICU. Patients in one unit will start off with Low Flow (LF) while the other unit will start off with High Flow (HF). After one half of the required sample size is accrued we will crossover the Medicine ICUs with the Surgical ICU.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes-Jewish Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy Watts, Barnes-Jewish Hospital
- Investigators
- Marin Kollef, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721419
- Sponsor's protocol ID
- 201707165
- Status last verified
- Jul 2019
- First submitted
- 29 Mar 2018
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
PubMed 19682735Jaber S, Jung B, Chanques G, Bonnet F, Marret E. Effects of steroids on reintubation and post-extubation stridor in adults: meta-analysis of randomised controlled trials. Crit Care. 2009;13(2):R49. doi: 10.1186/cc7772. Epub 2009 Apr 3.
PubMed 19344515Glossop AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012 Sep;109(3):305-14. doi: 10.1093/bja/aes270.
PubMed 22879654Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.
PubMed 16224108Nava 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 16276167
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Flow (LF) Oxygen Versus Heated Humidified High-Flow (HF) Therapy Following Tracheostomy
- ClinicalTrials.gov ID
- NCT03721419
- Acronym / sponsor ID
- 201707165
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Barnes-Jewish HospitalUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 26 Oct 2018 (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.
Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.
Detailed description
Many patients with Respiratory Failure undergo tracheostomy due to difficulty weaning from mechanical ventilation. A component of weaning a patient with tracheostomy usually involves the administration of oxygen via High Humidity device. There are two major ways of administering oxygen via High Humidity to patients. They include low flow high humidity; delivered at less than or equal to 10LPM or high-flow humidity, delivered at greater than 10LPM. There is not a currently accepted standard of practice for how to administer oxygen high humidity to patients who receive a tracheostomy due to respiratory failure. Both Low and High Flow high humidity devices are used routinely by health care facilities nationwide. Therefore, the investigators plan to perform a crossover study in both a medicine and surgical Intensive Care Unit to determine which type of oxygen High Humidity therapy should be preferentially utilized. Patients in one Intensive Care Unit will start off with Low Flow high humidity while the alternate unit will start with Hi Flow high humidity. After one half of the required sample size is accrued the investigators will cross over the two ICUs to the alternate type of oxygen High Humidity device. No other respiratory practices will change during the conduct of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover study between 2 medical ICUs and 1 Surgical ICU. Patients in one unit will start off with Low Flow (LF) while the other unit will start off with High Flow (HF). After one half of the required sample size is accrued we will crossover the Medicine ICUs with the Surgical ICU.
| Arm | Type | Receives |
|---|---|---|
| High Flow High Humidity device | Experimental | Device: High Flow High Humidity deviceHigh Flow High Humidity device arm subjects will be placed on a High Flow Airvo device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. This device has its own flow generator built in. |
| Low Flow High Humidity Device | Active comparator | Device: Low Flow High Humidity deviceLow Flow High Humidity device arm patients will be placed on a Low Flow device post tracheostomy with oxygen bled into system which maintains a safe level of patient blood oxygen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated patients who receive tracheostomy
Key exclusion criteria (1 listed)
- Non-English speaking and pregnancy
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 High Humidity deviceAlso: Airvo high flow deviceHigh Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2) | Device | High Flow High Humidity device |
| Low Flow High Humidity deviceAlso: High Humidity Trach CollarStandard high humidity trach collar utilizing venturi device bleed in | Device | Low Flow High Humidity Device |
Primary outcome
Days of Mechanical Ventilation (MV)
Time frame: an average of 1 year
Time in days from initiation of MV until discontinuance of MV
2 secondary outcomes
Days of ICU Stay
Time frame: an average of 1 year
Days of hospital stay
Time frame: an average of 1 year
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 20 Jul 2021.
- Background: PubMed 19682735Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
- Background: PubMed 19344515Jaber S, Jung B, Chanques G, Bonnet F, Marret E. Effects of steroids on reintubation and post-extubation stridor in adults: meta-analysis of randomised controlled trials. Crit Care. 2009;13(2):R49. doi: 10.1186/cc7772. Epub 2009 Apr 3.
- Background: PubMed 22879654Glossop AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012 Sep;109(3):305-14. doi: 10.1093/bja/aes270.
- Background: PubMed 16224108Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. doi: 10.1164/rccm.200505-718OC. Epub 2005 Oct 13.
- 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.
- Individual participant dataSharing planned: No
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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.
Marin Kollef, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow High Humidity device and Low Flow High Humidity device in people with Acute Respiratory Failure, run by Barnes-Jewish Hospital at 1 site 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 1 inclusion and 1 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 20 Jul 2021. 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 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?
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?
Days of Mechanical Ventilation (MV) (time frame: an average of 1 year). 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 NCT03721419, 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 20 Jul 2021.