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

Use of High-Flow Nasal Cannula to Prevent Desaturation Episodes in the Morbidly Obese Patients Undergoing Colonoscopy:A Prospective Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03148262
Enrollment
59
Registered
2017-05-10
Start date
2017-05-10
Completion date
2018-01-22
Last updated
2018-11-19

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

Conditions

Colonoscopy, Desaturation of Blood, High Flow Nasal Cannula, Obesity, Sleep Apnea

Brief 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.

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.

Interventions

DEVICEThe Salter nasal cannula

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

DEVICEThe Comfort Flo system

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

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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 ≥ 40

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

Design outcomes

Primary

MeasureTime frameDescription
The Number of Desaturation EpisodesPerioperative period during colonoscopyThe number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

Four subjects disqualified due to additional procedure, induction without propofol or using fentanyl.

Participants by arm

ArmCount
The High Flow Nasal Cannula
The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy The Comfort Flo system: The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation
28
The Standard Nasal Cannula
The Salter nasal cannula will be used during the colonoscopy The Salter nasal cannula: A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
31
Total59

Baseline characteristics

CharacteristicThe High Flow Nasal CannulaThe Standard Nasal CannulaTotal
Age, Continuous54 years
STANDARD_DEVIATION 7.9
59 years
STANDARD_DEVIATION 6.5
57 years
STANDARD_DEVIATION 7.5
Body Mass Index48 kg/m^2
STANDARD_DEVIATION 7
49 kg/m^2
STANDARD_DEVIATION 10
49 kg/m^2
STANDARD_DEVIATION 8.5
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants9 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants22 Participants42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
United States
28 participants31 participants59 participants
Sex: Female, Male
Female
24 Participants27 Participants51 Participants
Sex: Female, Male
Male
4 Participants4 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 31
other
Total, other adverse events
0 / 280 / 31
serious
Total, serious adverse events
0 / 280 / 31

Outcome results

Primary

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

ArmMeasureValue (MEDIAN)
The High Flow Nasal CannulaThe Number of Desaturation Episodes0 Episodes
The Standard Nasal CannulaThe Number of Desaturation Episodes0 Episodes

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026