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CompletedNCT03148262Updated Nov 19, 2018Results posted

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

An interventional study of The Comfort Flo system and The Salter nasal cannula in Desaturation of Blood, Obesity and Colonoscopy, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Desaturation of Blood
  • Obesity
  • Colonoscopy
  • Sleep Apnea
  • High Flow Nasal Cannula
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 59 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    The high flow nasal cannula

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

    Device: The Comfort Flo system

  • Placebo comparator
    The standard nasal cannula

    The Salter nasal cannula will be used during the colonoscopy

    Device: The Salter nasal cannula

Interventions

  • DeviceThe Comfort Flo system

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

    Also known as: High flow nasal cannula

  • DeviceThe Salter nasal cannula

    A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.

    Also known as: Standard nasal cannula

06

What researchers measure

Primary outcomes

  1. The Number of Desaturation Episodes

    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

07

Results

Posted Nov 19, 2018

Participant flow

A total of 63 subjects consented for the study. Four subjects disqualified.

Participant flow — Overall Study
MilestoneThe High Flow Nasal CannulaThe Standard Nasal Cannula
Started3132
Completed2831
Not completed31

Outcome measures

PrimaryThe Number of Desaturation Episodes

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
Reported as:
Median · Episodes
The Number of Desaturation Episodes
EpisodesThe High Flow Nasal CannulaThe Standard Nasal Cannula
The Number of Desaturation Episodes0 (0 to 1)0 (0 to 2)

Adverse events

Collected over Perioperative period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The High Flow Nasal Cannula0/28 (0%)0/28 (0%)0/28 (0%)
The Standard Nasal Cannula0/31 (0%)0/31 (0%)0/31 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)The High Flow Nasal CannulaThe Standard Nasal CannulaTotal
Mean54 ± 7.959 ± 6.557 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)The High Flow Nasal CannulaThe Standard Nasal CannulaTotal
Female242751
Male448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)The High Flow Nasal CannulaThe Standard Nasal CannulaTotal
Hispanic or Latino8917
Not Hispanic or Latino202242
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)The High Flow Nasal CannulaThe Standard Nasal CannulaTotal
United States283159
Body Mass Index
Body Mass Index(kg/m^2)The High Flow Nasal CannulaThe Standard Nasal CannulaTotal
Mean48 ± 749 ± 1049 ± 8.5
08

Study locations

2 sites
  • Parkland Helath Hospital System
    Dallas, Texas 75390, United States
  • Parkland Hospital
    Dallas, Texas 75390, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 22, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03148262
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Christina Riccio (Assistant Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
May 10, 2017
Start date
May 10, 2017
Primary completion
Aug 28, 2017
Completion
Jan 22, 2018
Results posted
Nov 19, 2018
Last update
Nov 19, 2018

Study contacts

Amanda Fox, MD
study director · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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