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The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients

A Prospective, Randomized Trial Comparing the Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients With High Risk of Obstructive Sleep Apnea Undergoing Colonoscopy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03479905
Enrollment
143
Registered
2018-03-27
Start date
2018-03-05
Completion date
2023-09-20
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desaturation of Blood, Colonoscopy

Brief summary

It is standard practice in the United States and many parts of world to perform Gastrointestinal endoscopy with the patient under deep intravenous 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, standard nasal cannula and standard face mask in morbidly obese patients with a high risk of sleep apnea, (BMI greater than 40, STOPBANG greater or equal to 5) receiving deep intravenous sedation during colonoscopies. This study will assess which method leads to a lower incidence of 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. 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. 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. 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. 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.

Interventions

OTHERSalter nasal cannula

Oxygen will be delivered via standard nasal cannula during colonoscopy

Oxygen will be delivered via face mask during colonoscopy

DEVICEHigh Flow Nasal Cannula

A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18-80 * Subjects undergoing colonoscopies * Morbidly obese BMI equal or greater than 40 * STOPBANG score equal or greater than 5

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 * Patients that received medications other than lidocaine and propofol

Design outcomes

Primary

MeasureTime frameDescription
Oxygen Saturation (SpO2 )Intraoperative period, an average of 1 hourThe frequency of desaturation episodes (SpO2 \<90%)

Countries

United States

Participant flow

Participants by arm

ArmCount
Salter Nasal Cannula
A Salter nasal cannula will be used at 4L/ minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 36% Salter nasal cannula: Oxygen will be delivered by using standard nasal cannula
43
Face Mask Group
A standard face mask will be used at 8L/minute during the colonoscopy. The FiO2 delivered to the patient at this rate has been shown to be equal to 60%. Face mask: Oxygen will be delivered via face mask during colonoscopy
43
High Flow Oxygen Delivery
Oxygen will be delivered by using high flow nasal cannula High Flow Nasal Cannula: A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
43
Total129

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyOther airway method used455

Baseline characteristics

CharacteristicSalter Nasal CannulaFace Mask GroupHigh Flow Oxygen DeliveryTotal
Age, Continuous56.55 years
STANDARD_DEVIATION 8.1
58.23 years
STANDARD_DEVIATION 6.73
57.55 years
STANDARD_DEVIATION 10.04
57.44 years
STANDARD_DEVIATION 8.36
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants12 Participants10 Participants33 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants31 Participants32 Participants93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants3 Participants
Preoperative oxygen saturation (SpO2)97.5 Percentage of oxygen saturation98 Percentage of oxygen saturation97 Percentage of oxygen saturation98 Percentage of oxygen saturation
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants22 Participants19 Participants62 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
White
20 Participants21 Participants23 Participants64 Participants
Region of Enrollment
United States
43 participants43 participants43 participants129 participants
Sex: Female, Male
Female
28 Participants31 Participants28 Participants87 Participants
Sex: Female, Male
Male
15 Participants12 Participants15 Participants42 Participants
Stop Bang Score6 Stop Bang Score on a scale of 0 to 86 Stop Bang Score on a scale of 0 to 86 Stop Bang Score on a scale of 0 to 86 Stop Bang Score on a scale of 0 to 8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 430 / 430 / 43
other
Total, other adverse events
0 / 430 / 430 / 43
serious
Total, serious adverse events
0 / 430 / 430 / 43

Outcome results

Primary

Oxygen Saturation (SpO2 )

The frequency of desaturation episodes (SpO2 \<90%)

Time frame: Intraoperative period, an average of 1 hour

ArmMeasureValue (MEDIAN)
Salter Nasal CannulaOxygen Saturation (SpO2 )0 Desaturation episodes
Face Mask GroupOxygen Saturation (SpO2 )0 Desaturation episodes
High Flow Oxygen DeliveryOxygen Saturation (SpO2 )0 Desaturation episodes
p-value: 0.0004Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026