Clinical trial NCT03529461: Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Official title: Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Obesity
Hypoxia
Keywords: severe obesity
non-invasive positive pressure ventilation
endoscopy
hypoxia
bariatric surgery
sedation
adverse events
BMI
anesthesia
complications
Lead sponsor: Bristol Hospital
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.

Detailed description: Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 \<=94%) and desaturation events requiring intervention (SpO2\<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.

Eligibility criteria: Inclusion Criteria:

* Weight loss surgery patients undergoing preoperative upper endoscopy
* BMI 40-60

Exclusion Criteria:

* Pregnant patients
* Previous weight loss surgery or stomach surgery
* BMI \> 60 and BMI \< 40
* Active smokers
* Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
* Lung disease, COPD asthma, cystic fibrosis, sarcoidosis
* Baseline O2 saturation less than or equal to 94%
* Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)

Primary outcomes:
measure: Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
timeFrame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
measure: Percentage of Participants With an Oxygen Desaturation Event < 90%
timeFrame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Secondary outcomes:
measure: Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
timeFrame: 3 minutes following a desaturation event < 90 %
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Bristol Hospital
state: Connecticut
Study officials:
affiliation: Bristol Hospital
name: Makram M Gedeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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