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

Primary Purpose

Gastric Distention

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Distention focused on measuring Gastric Ultrasound, Gastric Distension, Gastric Volume, Gastric Fluid Volume, High-flow oxygen therapy, HFHHNO, Healthy volunteer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2017
Last Updated
September 6, 2019
Sponsor
University Health Network, Toronto
Collaborators
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT03134937
Brief Title
High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension
Acronym
HFHHNOGastric
Official Title
Does High-Flow Heated and Humidified Nasal Oxygen Therapy (HFHHNO) Result in Gastric Distension? A Two-center Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Distention
Keywords
Gastric Ultrasound, Gastric Distension, Gastric Volume, Gastric Fluid Volume, High-flow oxygen therapy, HFHHNO, Healthy volunteer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every participant will recieve one HFHHNO session, will get 30 mins of oxygen up to 60-70 L/min.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)
Intervention Description
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 Measure Information:
Title
Change in Gastric Volume
Description
Ultrasound scan will be used to determine if there was an increase in gastric fluid volume following session of oxygen therapy.
Time Frame
Prior to, and immediately following session of HFHHNO oxygen therapy.
Secondary Outcome Measure Information:
Title
Gastric Distension
Description
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.
Time Frame
Immediately following session of HFHHNO oxygen therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery) Morbid obesity (Body Mass Index > 40 Kg/m2) Chronic Obstructive Pulmonary Disease (Emphysema or Chronic Bronchitis) Subjects diagnosed with type I and II Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anahi Perlas, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD is to be shared with other researchers. All data will be obtained during an gastric ultrasound scan.
Citations:
PubMed Identifier
32241548
Citation
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.
Results Reference
derived

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High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension

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