CompletedNot Applicable

Clinical Stabilization of Hypercapnia: NIPPV v HVNI

United States68 participantsStarted 2020-11-11

Plain-language summary

This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation \[NIPPV\].

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults, 18 years or older with a known or suspected diagnosis of COPD * Presentation with acute hypercapnic respiratory failure * Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher * Venous pH of 7.0 - 7.35 Exclusion Criteria: * Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder) * Need for airway protection * Primary condition of Congestive Heart Failure * Need for emergent intubation * Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia * Inability to provide informed consent * Pregnancy * Known contraindication to perform procedures listed, or therapies described in the protocol * Respiratory arrest or significant respiratory depression on presentation * Significant nasal occlusion either unilateral or bilateral * Absence of spontaneous respiration or known contraindication to HVNI * Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy * Determined by the clinician to be sufficiently unstable or unsuitable for this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rated Perceived Dyspnea [RPD]

Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min

Trial details

NCT IDNCT04709562

SponsorVapotherm, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-26

Results submitted2024-06-17

View on ClinicalTrials.gov More Hypercapnic Respiratory Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.