CompletedNot Applicable

High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension

Canada60 participantsStarted 2017-11-06

Plain-language summary

High Flow Heated and Humidified Nasal Oxygen therapy (HFHHNO) has been increasingly used in emergency medicine to assist patients with short term respiratory failure and to provide adequate oxygen to the body prior to intubation. Gastric distension which is the bloating of the stomach due to air being pumped into it is a concern for anesthesiologists as it increases the risk of nausea and vomiting during surgery (aspiration). The objective of this study is use an ultrasound machine to measure the volume of fluid in the stomach before and after HFNO is used in a standard clinical manner.

Who can participate

Age range

18 Years – 70 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

. Healthy volunteers aged 18 to 70 years
. Male or female
. American Society of Anesthesia physical status classification I and II
. Height greater than 145 cm
. Ability to understand the study protocol and provide informed consent. Communication difficulties will not be an impediment to participate. In case of a language barrier, translation services will be sought as per usual institutional practice.

Exclusion criteria

. Subjects predisposed to have an increased residual gastric volume at baseline (e.g. diabetes or known gastric dysmotility)

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

Change in Gastric Volume

Timeframe: Prior to, and immediately following session of HFHHNO oxygen therapy.

Trial details

NCT IDNCT03134937

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-20

View on ClinicalTrials.gov More Gastric Distention trials