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High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients

Primary Purpose

Desaturation of Blood, Obesity, Colonoscopy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Comfort Flo system
The Salter nasal cannula
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desaturation of Blood

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-80
  • Subjects undergoing colonoscopies
  • Morbidly obese BMI ≥ 40

Exclusion Criteria:

  • Subjects deemed hemodynamically unstable by the anesthesia team
  • Subjects who are an aspiration risk and will require endotracheal intubation.
  • Pregnancy
  • Subjects with an allergy to propofol
  • Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort
  • Subjects unwilling to sign consent
  • Chronic obstructive pulmonary disease
  • Patients that received medications other than lidocaine and propofol

Sites / Locations

  • Parkland Helath Hospital System
  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The high flow nasal cannula

The standard nasal cannula

Arm Description

The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy

The Salter nasal cannula will be used during the colonoscopy

Outcomes

Primary Outcome Measures

The Number of Desaturation Episodes
The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2017
Last Updated
November 15, 2018
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03148262
Brief Title
High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients
Official Title
Use of High-Flow Nasal Cannula to Prevent Desaturation Episodes in the Morbidly Obese Patients Undergoing Colonoscopy:A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is standard practice in the United States and many parts of world to perform Gastrointestinal (GI) endoscopy with the patient under deep sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The Obese population has a higher prevalence of obstructive sleep apnea (OSA) which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula and the standard nasal cannula in morbidly obese (BMI > 40) patients receiving deep intravenous sedation during colonoscopies. This study will assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative desaturation events compared to the current standard of care.
Detailed Description
The prevalence of morbid obesity is increasing worldwide. As the severity of obesity increases, the incidence of diagnosed obstructive sleep apnea also rises. Studies have shown an incidence of sleep apnea as high as 64% in patients with a body mass index (BMI) over 40 and 100% in patients with a BMI greater than 60. Patients with OSA have been shown to have significant desaturations under intravenous sedation due to airway narrowing and obstruction. Several studies have also shown that morbidly obese subjects, independent of a diagnosis of OSA, run a higher perioperative risk of adverse airway events, including hypoxia. Many morbidly obese subjects present to our institution for GI procedures under deep sedation. Providing anesthesia for this patient population is challenging and requires careful titration of drugs and superb airway management skills. The current standard of care for oxygen delivery in this setting is a Salter nasal cannula. There are no prospective, randomized studies that compare the use of a high flow humidified nasal cannula system and standard nasal cannula in morbidly obese patients presenting for colonoscopy under anesthesia. Humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21% to 100% FiO2 delivery and generates up to 60 L/min flow rates. The gas is heated (35 to 40 degree Celsius) and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the subject through a large diameter nasal cannula. Theoretically, HFNC offers significant advantages in oxygenation and ventilation over conventional methods (9). Constant high flow oxygen delivery provides steady inspired oxygen fraction (FiO2) and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation. In the current narrative review, Sotello et al. summarized factors explained the improvement in respiratory parameters by using HFNC. (1) Washout of the nasopharyngeal dead space; (2) Reduction in inspiratory resistance associated with gas flow through the nasopharynx; (3) Improvement in respiratory mechanical parameters associated with gas temperature and state of humidification; (4) Reduction in metabolic work associated with gas conditioning; (5) Provision of mild distending pressure. Some studies have demonstrated a positive effect of HFNC on the apnea-hypopnea index (AHI) showing that use of HFNC could decrease hypoxic episodes in subjects with repetitive upper airway obstruction such as obstructive sleep apnea. The STOP-BANG questionnaire (SB) has been used successfully to screen patients undergoing therapeutic endoscopic procedures at higher risk for sedation-related adverse events. We are hypothesizing that the HFNC will help maintain a patent airway and improve gaseous exchange in the morbidly obese patients undergoing deep sedation for colonoscopies and will result in a significant decrease in intraoperative desaturation events, thus improving morbidity and overall safety for this subgroup.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desaturation of Blood, Obesity, Colonoscopy, Sleep Apnea, High Flow Nasal Cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The high flow nasal cannula
Arm Type
Experimental
Arm Description
The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy
Arm Title
The standard nasal cannula
Arm Type
Placebo Comparator
Arm Description
The Salter nasal cannula will be used during the colonoscopy
Intervention Type
Device
Intervention Name(s)
The Comfort Flo system
Other Intervention Name(s)
High flow nasal cannula
Intervention Description
The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation
Intervention Type
Device
Intervention Name(s)
The Salter nasal cannula
Other Intervention Name(s)
Standard nasal cannula
Intervention Description
A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
Primary Outcome Measure Information:
Title
The Number of Desaturation Episodes
Description
The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.
Time Frame
Perioperative period during colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-80 Subjects undergoing colonoscopies Morbidly obese BMI ≥ 40 Exclusion Criteria: Subjects deemed hemodynamically unstable by the anesthesia team Subjects who are an aspiration risk and will require endotracheal intubation. Pregnancy Subjects with an allergy to propofol Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort Subjects unwilling to sign consent Chronic obstructive pulmonary disease Patients that received medications other than lidocaine and propofol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Fox, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Parkland Helath Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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High-Flow Nasal Cannula and Desaturation Episodes in the Morbidly Obese Patients

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