High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension

Not Applicable

Completed

• Conditions: Gastric Distention
• Interventions: Device: High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)

• Registration Number: NCT03134937
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

High Flow Heated and Humidified Nasal Oxygen therapy (HFHHNO) is being increasingly used in the emergency medicine and intensive care settings to manage patients with acute hypoxemic respiratory failure, and to optimize pre-oxygenation prior to intubation in patients with mild-to-moderate hypoxemia.

More recently, there have been reports of applications in the anesthesia perioperative setting. In fact, it is possible that the single greatest potential advantages of HFHHNO for anesthesia practice is that (unlike face mask and CPAP devices) oxygen administration can be maintained during periods of apnea with the potential to significantly prolong the apnea time available for safe and effective airway management.

However, the low levels of positive airway pressure associated with HFHHNO has raised the question of whether prolonged use could result in gastric insufflation thus increasing the risk of regurgitation and aspiration with an unprotected airway. Gastric distension is a concern for anesthesiologists because it leads to the activation of a parasympathetically-mediated reflex through the vagus nerve that leads to secretion of acetylcholine by enteric neurons. In turn, increased acetylcholine activates M3 receptors on parietal cells resulting in increased secretion of gastric acid. The combination of an increased volume of gastric secretions and high intraluminal pressure may place patients at risk of pulmonary aspiration.

The primary objective will be any change in gastric fluid volume from the baseline to each scan following HFHHNO therapy. Participants will undergo an abdominal ultrasound scan prior to any oxygen therapy to provide a baseline. One 30-minute session of oxygen therapy will follow(up to 60-70 L/min). After session, another ultrasound scan will take place, identical to the baseline to obtain the same measurements. From the images taken by the ultrasound, a mathematical model can be applied to calculate the gastric volume (and any change).

The secondary outcome will be the incidence of "gastric air distension" defined by qualitative ultrasound as a distended antrum with air content that blurs the posterior gastric wall.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-05-01
• Study Start: 2017-11-06
• Status Verified: 2019-02
• Primary Completion: 2019-03-20
• Study Completion: 2019-03-20
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)	Participants will undergo one session of high-flow heated and humidified oxygen therapy (HFHHNO) (up to 60-70 litre/min). They will undergo a gastric ultrasound scan after session of HFHHNO therapy.

Primary Outcome Measures

Name	Time	Method
Change in Gastric Volume	Prior to, and immediately following session of HFHHNO oxygen therapy.	Ultrasound scan will be used to determine if there was an increase in gastric fluid volume following session of oxygen therapy.

Secondary Outcome Measures

Name	Time	Method
Gastric Distension	Immediately following session of HFHHNO oxygen therapy.	The secondary outcome will be the incidence of "gastric air distension" defined by qualitative ultrasound as a distended antrum with air content that blurs the posterior gastric wall.

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada