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
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.
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.
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 →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.
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Exclusion Criteria:
The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy
Device: The Comfort Flo system
The Salter nasal cannula will be used during the colonoscopy
Device: The Salter nasal cannula
The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation
Also known as: High flow nasal cannula
A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
Also known as: Standard nasal cannula
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
A total of 63 subjects consented for the study. Four subjects disqualified.
| Milestone | The High Flow Nasal Cannula | The Standard Nasal Cannula |
|---|---|---|
| Started | 31 | 32 |
| Completed | 28 | 31 |
| Not completed | 3 | 1 |
The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.
| Episodes | The High Flow Nasal Cannula | The Standard Nasal Cannula |
|---|---|---|
| The Number of Desaturation Episodes | 0 (0 to 1) | 0 (0 to 2) |
Collected over Perioperative period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The High Flow Nasal Cannula | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| The Standard Nasal Cannula | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | The High Flow Nasal Cannula | The Standard Nasal Cannula | Total |
|---|---|---|---|
| Mean | 54 ± 7.9 | 59 ± 6.5 | 57 ± 7.5 |
| Sex: Female, Male(Participants) | The High Flow Nasal Cannula | The Standard Nasal Cannula | Total |
|---|---|---|---|
| Female | 24 | 27 | 51 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | The High Flow Nasal Cannula | The Standard Nasal Cannula | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 9 | 17 |
| Not Hispanic or Latino | 20 | 22 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | The High Flow Nasal Cannula | The Standard Nasal Cannula | Total |
|---|---|---|---|
| United States | 28 | 31 | 59 |
| Body Mass Index(kg/m^2) | The High Flow Nasal Cannula | The Standard Nasal Cannula | Total |
|---|---|---|---|
| Mean | 48 ± 7 | 49 ± 10 | 49 ± 8.5 |
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University of Texas Southwestern Medical Center