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AIRVO 2; new asymmetric nasal cannula for COPD exacerbation

N/A

Waitlist Available

Led By Gerard J Criner, MD

Research Sponsored by Temple University

Eligibility Criteria Checklist

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

Must have

i.aged ≥ 40 years (ii) hospitalization for acute exacerbation of COPD; (iii) smoker or ex-smoker (iv) FEV1 \<80% of predicted and FEV1/FVC \<70% postbronchodilator within 12 months prior to admission (v) have no other lung disease (including asthma) as a principal cause of pulmonary function limitation (vi) baseline PaCO2 ≥ 45 mm Hg at study entry. (vii) willing to give informed consent (viii) willing to participate in measurement of ABGs (ix) will to provide a brief history and physical examination and answer questionnaires.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of nasal tube that delivers oxygen to hospitalized patients with severe COPD. The new tube has a special shape that helps mix the air better, making it easier for patients to breathe and feel comfortable. The goal is to see if this new design improves patient comfort and breathing compared to the current tubes.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determining the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas.

Sensation of shortness of breath

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: AIRVO 2; new asymmetric nasal cannulaActive Control1 Intervention

The patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered

Group II: Conventional symmetric nasal cannulaActive Control1 Intervention

0 / 1Eligibility criteria met