Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

Not Applicable

Completed

Interventions: Device: Non-invasive positive pressure ventilation through nasal mask
Device: Rescue non-invasive positive pressure ventilation through nasal mask
Other: Secondary rescue maneuvers

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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Experimental	Non-invasive positive pressure ventilation through nasal mask	Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
Control	Rescue non-invasive positive pressure ventilation through nasal mask	Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Control	Secondary rescue maneuvers	Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Experimental	Secondary rescue maneuvers	Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%	Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).	Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Percentage of Participants With an Oxygen Desaturation Event < 90%	Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).	Percentage of participants who develop a peripheral oxygen saturation event \< 90%.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV	3 minutes following a desaturation event < 90 %	We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.