N/A
N=50
EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation
Obesity, Morbid
Bottom Line
View on ClinicalTrials.gov: NCT02590406 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Non Hypoxic Apnea Time — 216.7; 258.2 seconds — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Beach chair (BC) and ZEEP (Procedure); Reverse Trendelenburg and NIPPV (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Laval University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non Hypoxic Apnea Time |
216.7; 258.2 | 0.005 sig |
| SECONDARY Time to Expired Oxygen Fraction > 0,9 |
145.3; 85.1 | <0.0001 sig |
| SECONDARY Maximum Expired Fraction of Oxygen Obtained |
0.89; 0.91 | 0.0003 sig |
| SECONDARY Minimum Arterial Saturation of Oxygen Obtained |
83.6; 85.3 | 0.9 |
| SECONDARY Time to 97% Saturation |
88.4; 68 | 0.03 sig |
| SECONDARY Hemodynamic Changes |
— | — |
Summary
The risk of complication associated with airway in obese patient is important. The result of pre-oxygenation gives the clinician a prolonged non-hypoxic apnea time. The relation between FRC and non-hypoxic apnea time has been correlated. However, the best condition to accomplish the pre-oxygenation in morbidly obese patient has yet to be described in the medical literature. A study previously done in our hospital (EPO2-PV) compared the effect of different positions and ventilation modes on the FRC in the laboratory. A significant difference has been established on the FRC between the inverse Trendelenburg position with positive pressure ventilation and the head up ("beach-chair") position without positive pressure. The current study, EPO2-A is designed to compared the two positions and ventilation modes during the induction of general anesthesia on morbidly obese and correlate the difference in FRC to difference in apnea time.
Eligibility Criteria
Inclusion Criteria
- BMI > 40
- Abdominal obesity : waist circumference: > 115 for the women waist circumference > 130 for the men
Exclusion Criteria
- Facial hair
- Cranio-facial abnormality
- Asthma (continuous treatment)
- COPD (FEV1 3)
- Pregnancy
- Tobacco use
- Know or suspected difficulty with intubation
- Severe GERD or risk of aspiration
Data sourced from ClinicalTrials.gov (NCT02590406). 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.