Bariatric Surgery Candidate, Morbid Obesity
Conditions
Keywords
Morbid Obesity, Bariatric Surgery Candidate, Pre-Oxygenation, Functional Residual Capacity
Brief 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.
Detailed 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.
Interventions
Ventilation: non-invasive positive pressure ventilation (NIPPV) Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)
Tidal volume spontaneous ventilation, no assistance.
Sponsors
Study design
Eligibility
Inclusion criteria
* BMI 40 - 80 kg / m2 * Waist circumference: Men: More than 130 cm * Waist circumference: Women: More than 115 cm
Exclusion criteria
* Facial hair * Cranio-facial abnormality * Claustrophobia * Asthma * COPD (defined by FEV1 \< 80 %) * Severe cardiovascular disease (defined by NYHA ≥3) * Pregnancy * Tobacco use * NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Residual Capacity | After a 5 minutes pre-oxygenation period | Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic Amplitude. | After a 5 minutes pre-oxygenation period | Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described. |
| Respiratory Mechanics | At the end of a 5 minutes pre-oxygenation period | Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described. |
| Patient's Comfort | At the end of a 5 minutes pre-oxygenation period | Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | At the end of a 5 minutes pre-oxygenation period | Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described. |
Countries
Canada
Participant flow
Recruitment details
Recruitment was held between April 14th 2014 and June 26th 2014 by telephonic solicitation and through the preoperative bariatric clinic of our institution.
Participants by arm
| Arm | Count |
|---|---|
| Position and Spontaneous vs Pressure Support The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order.
Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Technical problem | 3 |
Baseline characteristics
| Characteristic | Position and Spontaneous vs Pressure Support |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 9.7 |
| BMI | 50 kg/m2 STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 5 Participants |
| Waist circumference | 143 cm STANDARD_DEVIATION 17 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Functional Residual Capacity
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.
Time frame: After a 5 minutes pre-oxygenation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1. Supine + NIPPV | Functional Residual Capacity | 2573 ml | Standard Deviation 515 |
| 2. Supine + Tidal Volume Spontaneous Ventilation | Functional Residual Capacity | 2145 ml | Standard Deviation 438 |
| 3. Beach Chair (Back 25 Deg) + NIPPV | Functional Residual Capacity | 2456 ml | Standard Deviation 442 |
| 4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous Ventil | Functional Residual Capacity | 2219 ml | Standard Deviation 477 |
| 5. Proclive (Global 25 Deg) + NIPPV | Functional Residual Capacity | 2684 ml | Standard Deviation 473 |
| 6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous Ventila | Functional Residual Capacity | 2282 ml | Standard Deviation 501 |
Diaphragmatic Amplitude.
Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time frame: After a 5 minutes pre-oxygenation period
Patient's Comfort
Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time frame: At the end of a 5 minutes pre-oxygenation period
Respiratory Mechanics
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time frame: At the end of a 5 minutes pre-oxygenation period
Vital Signs
Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time frame: At the end of a 5 minutes pre-oxygenation period