High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension (HFHHNOGastric)

Does High-Flow Heated and Humidified Nasal Oxygen Therapy (HFHHNO) Result in Gastric Distension? A Two-center Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Gastric Distention
• Intervention / Treatment: Device: High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Healthy volunteers aged 18 to 70 years
2. Male or female
3. American Society of Anesthesia physical status classification I and II
4. Height greater than 145 cm
5. 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

1. Subjects predisposed to have an increased residual gastric volume at baseline (e.g. diabetes or known gastric dysmotility)
2. History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
3. Morbid obesity (Body Mass Index > 40 Kg/m2)
4. Chronic Obstructive Pulmonary Disease (Emphysema or Chronic Bronchitis)
5. Subjects diagnosed with type I and II Diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Study Arm; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric Distension	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.	Immediately following session of HFHHNO oxygen therapy.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Kaiser Permanente

Publications and helpful links

General Publications

• McLellan E, Lam K, Behringer E, Chan V, Bozak D, Mitsakakis N, Perlas A. High-flow nasal oxygen does not increase the volume of gastric secretions during spontaneous ventilation. Br J Anaesth. 2020 Jul;125(1):e75-e80. doi: 10.1016/j.bja.2020.02.023. Epub 2020 Mar 31.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ACTUAL): March 20, 2019
• Study Completion (ACTUAL): March 20, 2019

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): May 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Healthy volunteer; Gastric Volume; Gastric Ultrasound; High-flow oxygen therapy; Gastric Distension; Gastric Fluid Volume; HFHHNO
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 17-5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD is to be shared with other researchers. All data will be obtained during an gastric ultrasound scan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No