Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, Effects on Oxygenation in Hypoxic COVID-19 Patients. Prospective Cohort Study.

An observational study of COVID -19 and Respiratory Failure, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19. Read more about this study

Who is it for?: Any age
Conditions the study is for: COVID -19, Respiratory Failure, Hypoxia
What is being tested?: Oxygen Hood
Type of treatment: Medical device
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2020to 1 May 2020
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All COVID-19 patients presenting to the hospital prior to the availability of oxygen hoods were reviewed for eligibility and assignment to the control cohort. All COVID-19 patients presenting to the hospital after the availability of oxygen hoods were reviewed for eligibility and assignment to the intervention cohort if they were failing on conventional high-flow oxygen delivery systems.

Who may be able to join

Hospital census is reviewed for ALL patients seen in the Emergency Department admitted with COVID -19 diagnosis and experiencing hypoxia requiring supplemental high-flow oxygen delivery or who have required mechanical ventilation.
Consent (native language services provided).
No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, DNR/DNI status.

Who cannot join

SaO2 > 90% on conventional high-flow O2-delivery system.
Confinement anxiety post-oxygen hood placement with request for removal.

Trial locations and contacts

1 site in 1 country.

United States1 site

Phelps Hospital
Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: The Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.

Read the detailed description

To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of hospitalization, and in-hospital mechanical ventilation and mortality rates in Covid-19 patients when compared to conventional high-flow oxygen delivery systems. Oxy-hemoglobin saturation is continuously measured by pulse-oximetry including immediately before and after oxygen hood placement, and will be measured in controls.

Comparison/Control Group The control cohort includes COVID-19 patients presenting for treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. Patients maintained on, or those failing on conventional O2- delivery systems and subsequently receiving mechanical ventilation will be studied.

All patients included must have tested positive using PCR swabs and/or been diagnosed based on clinical/laboratory standard diagnostic criteria. Medical management will include evolving treatment regimens and other standard medical treatments widely used at time of study in all hypoxic COVID-19 patients.

Prognostic/confounding covariates are to be collected through Electronic Medical Record (EMR) chart review and compared between intervention and control cohorts. including: Age, Body Mass Index (BMI), Gender, Chronic Lung disease - COPD, Asthma (CLD), cardiovascular disease - CAD, CHF, Chronic Dysrhythmia (CVD), chronic kidney disease (CKD), Immunosuppression - History of Cancer, Immunosuppressive medication, HIV (Immunosuppression), Diabetes Mellitus (DM), and pertinent lab markers.

Routine follow-up evaluation is maintained until final in-hospital outcomes are known including:

Oxygen Difference pre/post-hood (SaO2 difference, %)
Intubation/MV status (Intubated)
Survival/Mortality (Expired)
Hospital Length of Stay (LOS, days)

Randomization/Blinding Randomization is not possible as it is unethical to deny a hypoxic patient an alternative approved means of oxygenation for patients failing on conventional oxygen delivery systems. No blinding of participants or investigators.

Conditions: COVID -19, Respiratory Failure, Hypoxia
Being tested: Oxygen Hood
Medical subject headings: COVID-19, Respiratory Insufficiency, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxygen HoodDevice
Also called Oxygen Helmets
High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.

Study groups in NCT04407260
Study group	Role	What they receive
Intervention		Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems. Receives: Device: Oxygen Hood
Control		Patients maintained on conventional high-flow oxygen delivery systems (such as non-rebreather masks, high-flow nasal cannula, BiPAP, CPAP) or who have failed on these conventional symptoms and were subsequently mechanically ventilated.

What is being measured

The primary outcome is the main question the study is designed to answer.

Oxygen saturation
Continuous pulse oximetry monitoring
Measured: 3/6/2020 - 5/1/2020
In-hospital Intubation/Mechanical Ventilation Status
Intubation/mechanical Ventilation at any point during hospitalization.
Measured: 3/6/2020 - 5/1/2020
In-hospital Mortality
In-hospital Mortality status
Measured: 3/6/2020 - 5/1/2020
Length of Hospitalization
Duration of hospitalization
Measured: 3/6/2020 - 5/1/2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 20201 May 2020

First posted29 May 2020
Study start6 Mar 2020
Primary completion1 May 2020
Study completion1 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for COVID -19Studies of the same condition, open and under way.
More trials run by Northwell HealthThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04407260
Sponsor's protocol ID: HoodStudy701
Status last verified: Nov 2022
First submitted: 27 May 2020
Last updated: 2 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: If other researchers are investigating similar research question will consider sharing IPD.

Publications

Organization WH. Rolling updates on Coronavirus disease (COVID - 19) - Coronavirus disease (COVID-19) Situation Report.: World Health Organization, 2020.
Control CfD. Recommended Preparedness and Response Activities in Healthcare. Supplement C: Preparedness and Response In Healthcare Facilities. Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS) Version 2/3.
Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003
Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020 Dec 17;383(25):2451-2460. doi: 10.1056/NEJMcp2009575. Epub 2020 May 15. No abstract available.
PubMed 32412710
Health. NDo. Amid Ongoing COVID-19 Pandemic, Governor Cuomo Announces State Department of Health Has Approved New Protocol to Allow BiPAP Machines to be Converted Into Ventilators.
Wang L, He W, Yu X, Hu D, Bao M, Liu H, Zhou J, Jiang H. Coronavirus disease 2019 in elderly patients: Characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639-645. doi: 10.1016/j.jinf.2020.03.019. Epub 2020 Mar 30.
PubMed 32240670
Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
PubMed 27179847
Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.
PubMed 29595563
K M. Oxygen Administration: What Is the Best Choice? Respiratory Therapy 2015.
Department of Health and Human Services - Food and drug Administration - Conference of CDRH OoDEO. Device Evaluation and Approval., 2002.
UN-TBftLDC. Local production could solve shortages of essential pandemic-fighting equipment., 2020.
MEDICINE. ECFH. ECHM position on Hyperbaric Oxygen Therapy (HBOT) in multiplace hyperbaric chambers during coronavirus disease (COVID-19) outbreak.
B L, A C, Z B, et al. COVID-19: Oxygen Escalation Therapy and Noninvasive Ventilation. EmDocs 2020. http://www.emdocs.net/covid-19-oxygen-escalation-therapy-and-noninvasive-ventilation/ (accessed April 15, 2020).
Prevention CfDCa. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). 2020.
Ashraf-Kashani N, R K. High-flow nasal oxygen therapy. BJA Education;17(2):57-62.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.
ClinicalTrials.gov ID: NCT04407260
Acronym / sponsor ID: HoodStudy701
Conditions: COVID -19, Respiratory Failure, Hypoxia
Study type: Observational
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 6 Mar 2020 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 1 May 2020 (actual)
First posted: 29 May 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.

Detailed description

Routine follow-up evaluation is maintained until final in-hospital outcomes are known including:

Oxygen Difference pre/post-hood (SaO2 difference, %)
Intubation/MV status (Intubated)
Survival/Mortality (Expired)
Hospital Length of Stay (LOS, days)

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Intervention	–	Device: Oxygen HoodPatients on oxygen hoods who have fail conventional high-flow oxygen delivery systems.
Control	–	–Patients maintained on conventional high-flow oxygen delivery systems (such as non-rebreather masks, high-flow nasal cannula, BiPAP, CPAP) or who have failed on these conventional symptoms and were subsequently mechanically ventilated.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All COVID-19 patients presenting to the hospital prior to the availability of oxygen hoods were reviewed for eligibility and assignment to the control cohort. All COVID-19 patients presenting to the hospital after the availability of oxygen hoods were reviewed for eligibility and assignment to the intervention cohort if they were failing on conventional high-flow oxygen delivery systems.

Key inclusion criteria (3 listed)

Hospital census is reviewed for ALL patients seen in the Emergency Department admitted with COVID -19 diagnosis and experiencing hypoxia requiring supplemental high-flow oxygen delivery or who have required mechanical ventilation.
Consent (native language services provided).
No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, DNR/DNI status.

Key exclusion criteria (2 listed)

SaO2 > 90% on conventional high-flow O2-delivery system.
Confinement anxiety post-oxygen hood placement with request for removal.

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
Oxygen HoodAlso: Oxygen HelmetsHigh-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.	Device	Intervention

Primary outcome

Oxygen saturation
Time frame: 3/6/2020 - 5/1/2020
Continuous pulse oximetry monitoring
In-hospital Intubation/Mechanical Ventilation Status
Time frame: 3/6/2020 - 5/1/2020
Intubation/mechanical Ventilation at any point during hospitalization.
In-hospital Mortality
Time frame: 3/6/2020 - 5/1/2020
In-hospital Mortality status
Length of Hospitalization
Time frame: 3/6/2020 - 5/1/2020
Duration of hospitalization

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 2 Dec 2022.
BackgroundOrganization WH. Rolling updates on Coronavirus disease (COVID - 19) - Coronavirus disease (COVID-19) Situation Report.: World Health Organization, 2020.
BackgroundControl CfD. Recommended Preparedness and Response Activities in Healthcare. Supplement C: Preparedness and Response In Healthcare Facilities. Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS) Version 2/3.
Background: PubMed 32320003Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
Background: PubMed 32412710Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020 Dec 17;383(25):2451-2460. doi: 10.1056/NEJMcp2009575. Epub 2020 May 15. No abstract available.
BackgroundHealth. NDo. Amid Ongoing COVID-19 Pandemic, Governor Cuomo Announces State Department of Health Has Approved New Protocol to Allow BiPAP Machines to be Converted Into Ventilators.
Background: PubMed 32240670Wang L, He W, Yu X, Hu D, Bao M, Liu H, Zhou J, Jiang H. Coronavirus disease 2019 in elderly patients: Characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639-645. doi: 10.1016/j.jinf.2020.03.019. Epub 2020 Mar 30.
Background: PubMed 27179847Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
Background: PubMed 29595563Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.
BackgroundK M. Oxygen Administration: What Is the Best Choice? Respiratory Therapy 2015.
BackgroundDepartment of Health and Human Services - Food and drug Administration - Conference of CDRH OoDEO. Device Evaluation and Approval., 2002.
BackgroundUN-TBftLDC. Local production could solve shortages of essential pandemic-fighting equipment., 2020.
BackgroundMEDICINE. ECFH. ECHM position on Hyperbaric Oxygen Therapy (HBOT) in multiplace hyperbaric chambers during coronavirus disease (COVID-19) outbreak.
Individual participant dataSharing planned: Undecided. If other researchers are investigating similar research question will consider sharing IPD.

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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.

David Dayya, DO, PhD, MPH principal investigator

Phelps Hospital - Northwell Health

Owen J O'Neill, MD, MPH principal investigator

Phelps Hospital - Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID -19 and Respiratory Failure, run by Northwell Health 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 3 inclusion and 2 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 2 Dec 2022. 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?

Oxygen saturation (time frame: 3/6/2020 - 5/1/2020). The study lists 4 primary outcomes in all. 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 NCT04407260, which also lists 19 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 2 Dec 2022.