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Device

Noninvasive Ventilation Modes for Hypercapnic Respiratory Failure

N/A

Recruiting

Led By Margarita Oks, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hypercapnic respiratory failure on admission (ABG)

Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial compares two modes of noninvasive ventilation to find which is more effective for treating hypercapnic respiratory failure.

Who is the study for?

This trial is for adults over 18 with hypercapnic respiratory failure who need noninvasive ventilation. They must consent to study procedures and be available throughout the study. Excluded are those without spontaneous breathing, pregnant women, intubated patients, individuals unable to clear airways or at risk of aspiration.Check my eligibility

What is being tested?

The study compares two noninvasive ventilation methods: AVAPS and BIPAP S/T in treating hypercapnic respiratory failure. It aims to see if AVAPS reduces ICU or telemetry stay compared to BIPAP S/T, which is a standard care approach.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the masks, skin irritation where the mask touches the face, dry mouth or nosebleeds due to airflow pressure, and possible stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with too much carbon dioxide in my blood when admitted.

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I need a machine to help me breathe due to high CO2 levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ICU length of stay of telemetry length of stay

Secondary outcome measures

Days on NIV

Difference in PaCO2 value with NIV

Need for ICU stay

+9 more

Trial Design

2Treatment groups

Active Control

Group I: Average Volume-Assured Pressure Support (AVAPS)Active Control1 Intervention

Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

Group II: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)Active Control1 Intervention

Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,943 Total Patients Enrolled

Margarita Oks, MDPrincipal InvestigatorLenox Hill Hospital/Northwell Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this trial available at present?

"The trial that was posted on September 15th 2023 and last edited three days later is not currently recruiting. However, 184 separate clinical trials are actively searching for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP

2023. "NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047405.