Clinical trial NCT02590406: EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation
Official title: EPO2-A: Evaluation of Different Pre-Oxygenation Condition in Morbid Obesity: Effect of Position and Positive Pressure Ventilation During General Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Morbid Obesity
Bariatric Surgery
Pre-Oxygenation
Anesthesia Induction
Positive pressure ventilation
Non hypoxic apnea time
Positive-Pressure Respiration
Anesthesia, General
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Obesity prevalence in the population is increasing. Thus a growing number of obese patient need surgical interventions. These patients have a four time higher risk of suffering of serious complication in relation with their airway management compare with non-obese patients. This is explained by an increased incidence of difficulty with the ventilation and intubation of the obese. The time available for the clinician to manage the airway is define by the non hypoxic apnea time. This laps of time is dependent of the oxygen stocks of the patient, which are dependent of the functional residual capacity (FRC) and his oxygen consumption. For a non-obese patient, a normal pre-oxygenation of three minutes at 100% of oxygen allows a non hypoxic apnea time (oxygen saturation \> 90%) of 8,9 minutes. However, for the morbidly obese, this time is cut to less than three minutes.

The major goal of the pre-oxygenation is to increase the alveolar partial pressure of oxygen available in the end-expiratory pulmonary volume. This can be done by replacing the nitrogen in the alveolus by oxygen and by increasing the pulmonary stocks, the FRC. It has been demonstrated that the FRC after the induction of anesthesia is cut by half for the obese. This reduction is explained by a diminished thoracic compliance and an increase of the dependent lung regions' atelectasis because of a more cephalic position of the diaphragm.

Various pre-oxygenation methods have been described to prolong the non hypoxic apnea time in the obese population. Some proposed pre-oxygenation strategies with the patient in the head up position (beach chair). It is a position derived from the ramped position described as the best to visualized the obese patients' glottis. Others proposed pre-oxygenation strategies with positive pressure ventilation, but only the supine position has been studied concomitantly.

Individually, these techniques of pre-oxygenation are superior to the combination of supine position and no positive pressure. Indeed, studies demonstrated that the beach chair position (derived from the ramped position) or the positive pressure pre-oxygenation in supine position diminished the time needed to obtain a satisfactory pre-oxygenation (End-expiratory oxygen fraction \>0,9) and a longer non hypoxic apnea time. Sill, these strategies have never been combined in the same protocol.

The beach chair position without positive pressure ventilation has become the standard of care because it is the position that allows the best glottis view. Though, it has been shown by Boyce and coll. that the reverse Trendelenburg position, and not the beach chair, increased the non hypoxic apnea time, the recuperation time and the minimal saturation obtained compared to the supine position. We think that there is an advantage to use the reverse Trendelenburg position to optimize the non hypoxic apnea time. Indeed, our hypothesis is that there will be less pressure on the diaphragm in comparison with the beach char position.

A studied realized by our group (EPO2-PV) evaluated the effect of three positions (Reverse Trendelenburg, beach chair and supine) and two ventilation strategies (spontaneous ventilation with or without positive pressure) on morbidly obese FRC in laboratory. The results showed a statistically significant difference on the FRC after a pre-oxygenation with positive pressure compared with the pre-oxygenation without positive pressure, and this regardless of the position. Moreover, for both ventilation strategies, results demonstrated a statistically significant superiority between the FRC obtained after pre-oxygenation in reverse Trendelenburg compared with the beach chair and the supine position. No improvement has been shown with the beach chair position.

Thereby, the current study will try to correlate the FRC results obtained in laboratory in actual non hypoxic apnea time in the operating room. This research design tries to compare, in patient receiving general anesthesia for bariatric surgeries, the effect of the pre-oxygenation with positive pressure and the reverse Trendelenburg position, on the non hypoxic apnea time in comparison with the actual standard of care, beach chair position without positive pressure ventilation.

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 \< 80%)
* Severe cardiovascular disease (NYHA \> 3)
* Pregnancy
* Tobacco use
* Know or suspected difficulty with intubation
* Severe GERD or risk of aspiration

Primary outcomes:
measure: Non Hypoxic Apnea Time
timeFrame: After a 3 minutes pre-oxygenation period
Secondary outcomes:
measure: Time to Expired Oxygen Fraction > 0,9
timeFrame: During the pre-oxygenation period
measure: Maximum Expired Fraction of Oxygen Obtained
timeFrame: After 3 minutes of pre-oxygenation
measure: Minimum Arterial Saturation of Oxygen Obtained
timeFrame: After the end of the Non-hypoxic apnea time
measure: Time to 97% Saturation
timeFrame: Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%
measure: Hemodynamic Changes
timeFrame: From the beginning of the pre-oxygenation to the end of the protocol
Other outcomes:
Locations:
city: Québec city
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Laval University
name: Antony Carrier-Boucher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Bussières S Jean, MD
role: PRINCIPAL_INVESTIGATOR
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