The Use of High Flow Nasal Cannula, Standard Face Mask and Standard Nasal Cannula in Morbidly Obese Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/27/2018 |
| Start Date: | March 5, 2018 |
| End Date: | November 25, 2019 |
| Contact: | Christina Riccio, MD |
| Email: | Christina.Riccio@UTSouthwestern.edu |
| Phone: | 469-419-8446 |
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
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.
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.
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.
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.
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
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