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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Terminated

Conditions

Desaturation of Blood
Colonoscopy

Treatments

Device: High Flow Nasal Cannula
Other: Face mask
Other: Salter nasal cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT03479905
STU 102017-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

143 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

143 participants in 3 patient groups

Salter nasal cannula
Sham Comparator group
Description:
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%
Treatment:
Other: Salter nasal cannula
Face mask group
Sham Comparator group
Description:
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%.
Treatment:
Other: Face mask
High Flow Oxygen delivery
Experimental group
Description:
Oxygen will be delivered by using high flow nasal cannula
Treatment:
Device: High Flow Nasal Cannula

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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