Mechanical VentilationNCT04349332
Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
A study testing Helmet non-invasive ventilation (NIV) in people with Mechanical Ventilation and Corona Virus Infection, run by University of Chicago at 1 site in United States.
Trial summary
The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Corona Virus Infection
- What is being tested?
- Helmet non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 9 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
- Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6 pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously breathe
Who cannot join
- Hemodynamic instability (Systolic blood pressure <90 or requiring >2 vasoactive agents) Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.
Read the detailed description
Single center randomized clinical trial investigating the efficacy of helmet NIV used for early liberation from mechanical ventilation in patients with acute hypoxemic respiratory failure.
Intervention: Helmet group Patients randomized to the intervention group will be extubated to helmet NIV without a spontaneous breathing trial. The helmet will be connected to oxygen and room air flow meter to deliver a minimum of 60L of fresh gas flow and a PEEP valve. The PEEP will be increased using a PEEP valve in increments of 2-3 cmH20 to improve peripheral oxygen saturation of at least 90% at an inspired oxygen requirement (FiO2) of ≤ 60%.14 After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; this is a part of usual care for the management of patients with acute hypoxemic respiratory failure. Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Control: Usual Care Patient randomized to the control group will continue invasive mechanical ventilation until the following weaning criteria are met:15 Resolution or improvement of the condition leading to intubation Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mm Hg and heart rate less than 140/min without vasopressors or with low doses of vasopressors Glasgow Coma Scale score of 13 or greater Respiratory stability (oxygen saturation >90% with fraction of inspired oxygen [Fio2] ≤0.4, respiratory rate <35/min, Noncopious secretions (<3 aspirations in the last 8 hours).
Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes on pressure support mode. Criteria for failure to tolerate the SBT were agitation, anxiety, low level of consciousness (Glasgow Coma Scale score <13), respiratory rate higher than 35/min and/or use of accessory muscles, oxygen saturation by pulse oximetry less than 90% with Fio2 higher than 0.5, heart rate higher than 140/min or greater than a 20% increase from baseline, systolic blood pressure lower than 90 mm Hg, or development of arrhythmia. If the spontaneous breathing trial is successful, then the patient will be extubated.
Subjects will be followed for long term followup at 90 day and 1year mortality
- Conditions
- Mechanical Ventilation, Corona Virus Infection
- Being tested
- Helmet non-invasive ventilation (NIV)
- Keywords
- helmet interface NIV, early extubation, acute hypoxemic respiratory failure
- Medical subject headings
- Coronavirus Infections, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet non-invasive ventilation (NIV)Device
After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
| Study group | Role | What they receive |
|---|---|---|
| Helmet non invasive ventilation (NIV) | Active comparator | Patients randomized to the intervention group will be extubated to helmet NIV. Receives: Device: Helmet non-invasive ventilation (NIV) |
| Control invasive mechanical ventilation | No intervention | Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator days
duration of mechanical ventilation via endotracheal tube
Measured: up to 4 weeks
Secondary outcomes (2)
Intensive care unit (ICU) length of stay
number of days admitted to the ICU
Measured: up to 6 weeks
need for re-intubation
number of patients requiring endotracheal intubation after extubation
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start13 Aug 2020
- Primary completion9 Jan 2024 (estimated)
- Study completion9 Jan 2024
Why it stopped: the study was not initiated, no subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Model description
- randomized trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349332
- Sponsor's protocol ID
- IRB20-0594
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04349332
- Acronym / sponsor ID
- IRB20-0594
- Conditions
- Mechanical Ventilation, Corona Virus Infection
- Keywords
- helmet interface NIV, early extubation, acute hypoxemic respiratory failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study was not initiated, no subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 9 Jan 2024 (estimated)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 16 Apr 2020 (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.
The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.
Detailed description
Single center randomized clinical trial investigating the efficacy of helmet NIV used for early liberation from mechanical ventilation in patients with acute hypoxemic respiratory failure.
Intervention: Helmet group Patients randomized to the intervention group will be extubated to helmet NIV without a spontaneous breathing trial. The helmet will be connected to oxygen and room air flow meter to deliver a minimum of 60L of fresh gas flow and a PEEP valve. The PEEP will be increased using a PEEP valve in increments of 2-3 cmH20 to improve peripheral oxygen saturation of at least 90% at an inspired oxygen requirement (FiO2) of ≤ 60%.14 After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; this is a part of usual care for the management of patients with acute hypoxemic respiratory failure. Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Control: Usual Care Patient randomized to the control group will continue invasive mechanical ventilation until the following weaning criteria are met:15 Resolution or improvement of the condition leading to intubation Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mm Hg and heart rate less than 140/min without vasopressors or with low doses of vasopressors Glasgow Coma Scale score of 13 or greater Respiratory stability (oxygen saturation >90% with fraction of inspired oxygen [Fio2] ≤0.4, respiratory rate <35/min, Noncopious secretions (<3 aspirations in the last 8 hours).
Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes on pressure support mode. Criteria for failure to tolerate the SBT were agitation, anxiety, low level of consciousness (Glasgow Coma Scale score <13), respiratory rate higher than 35/min and/or use of accessory muscles, oxygen saturation by pulse oximetry less than 90% with Fio2 higher than 0.5, heart rate higher than 140/min or greater than a 20% increase from baseline, systolic blood pressure lower than 90 mm Hg, or development of arrhythmia. If the spontaneous breathing trial is successful, then the patient will be extubated.
Subjects will be followed for long term followup at 90 day and 1year mortality
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized trial
| Arm | Type | Receives |
|---|---|---|
| Helmet non invasive ventilation (NIV) | Active comparator | Device: Helmet non-invasive ventilation (NIV)Patients randomized to the intervention group will be extubated to helmet NIV. |
| Control invasive mechanical ventilation | No intervention | –Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6 pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously breathe
Key exclusion criteria (1 listed)
- Hemodynamic instability (Systolic blood pressure <90 or requiring >2 vasoactive agents) Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
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 non-invasive ventilation (NIV)After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay. | Device | Helmet non invasive ventilation (NIV) |
Primary outcome
ventilator days
Time frame: up to 4 weeks
duration of mechanical ventilation via endotracheal tube
2 secondary outcomes
Intensive care unit (ICU) length of stay
Time frame: up to 6 weeks
need for re-intubation
Time frame: up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 non-invasive ventilation (NIV) in people with Mechanical Ventilation and Corona Virus Infection, run by University of Chicago 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: withdrawn, as of the sponsor's last update on 2 May 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
ventilator days (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2024.