Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Obesity
- Sponsor
- Bristol Hospital
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Makram Gedeon, MD
Medical director of bariatric surgery program, principal investigator
Bristol Hospital
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)
Outcomes
Primary Outcomes
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Time Frame: 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 Frame: 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 Outcomes
- 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 %)