N/A
N=56
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Severe Obesity · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT03529461 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Percentage of Participants With an Oxygen Desaturation Event ≤ 94% — 57.1; 14.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-invasive positive pressure ventilation through nasal mask (Device); Rescue non-invasive positive pressure ventilation through nasal mask (Device); Secondary rescue maneuvers (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol Hospital
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Oxygen Desaturation Event ≤ 94% |
57.1; 14.3 | — |
| PRIMARY Percentage of Participants With an Oxygen Desaturation Event < 90% |
28.6; 3.5 | — |
| SECONDARY Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV |
8 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03529461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.