N/A Completed N=50 Randomized Single-blind Prevention

EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation

Obesity, Morbid

Source: ClinicalTrials.gov NCT02590406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcomePrimary: Non Hypoxic Apnea Time — 216.7; 258.2 seconds — p=0.005

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.

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.