EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode — EPO2-PV  

Morbid Obesity Clinical Trial

Official title: Evaluation of Different Pre-Oxygenation Conditions in Morbid Obesity: Position and Ventilation Mode, in a Respiratory Physiology Laboratory, on Voluntary Subjects

Status Completed

Clinical Trial Summary

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.

This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

Clinical Trial Description

Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.

Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.

The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.

Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.

We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure. ;

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Morbid Obesity
• Obesity
• Obesity, Morbid

• NCT number: NCT02121808
• Study type: Interventional
• Source: Laval University
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Completion date: July 2014