Obesity, Morbid
Conditions
Keywords
Morbid Obesity, Bariatric Surgery, Pre-Oxygenation, Anesthesia Induction, Positive pressure ventilation, Non hypoxic apnea time, Positive-Pressure Respiration, Anesthesia, General
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.
Interventions
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up. NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Hypoxic Apnea Time | After a 3 minutes pre-oxygenation period | Change of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP. End of measure time frame is 5 minutes after intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Expired Oxygen Fraction > 0,9 | During the pre-oxygenation period | Evaluation of time needed to obtain an expired fraction of oxygen of \> 0,9 in the two groups during the pre-oxygenation |
| Maximum Expired Fraction of Oxygen Obtained | After 3 minutes of pre-oxygenation | Evaluation of the maximum expired oxygen fraction obtained in the two groups |
| Minimum Arterial Saturation of Oxygen Obtained | After the end of the Non-hypoxic apnea time | Evaluation of the minimal saturation obtained after the resumption of the ventilation |
| Time to 97% Saturation | Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97% | — |
| Hemodynamic Changes | From the beginning of the pre-oxygenation to the end of the protocol | Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode |
Countries
Canada
Participant flow
Recruitment details
Recruitment between September and December 2015 on the bariatric surgery ward during the preoperative assessment.
Pre-assignment details
Files were evaluated in order to see if the patients met the inclusion criteria, if they had any exclusion criteria. Then the trial was explained to them and they could choose wether they wanted to participate or not. 75 patients files were evaluated, 53 were solicitated, 3 refused to participate.
Participants by arm
| Arm | Count |
|---|---|
| Beach Chair (BC) and ZEEP Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Beach chair (BC) and ZEEP: Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface | 24 |
| Reverse Trendelenburg and NIPPV Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface
Reverse Trendelenburg and NIPPV: Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Saturometer malfunction | 0 | 1 |
Baseline characteristics
| Characteristic | Beach Chair (BC) and ZEEP | Reverse Trendelenburg and NIPPV | Total |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.1 | 40.8 years STANDARD_DEVIATION 8.5 | 43.5 years STANDARD_DEVIATION 10.2 |
| BMI (m/kg2) | 47.3 kilogram per meter square STANDARD_DEVIATION 5.2 | 47.9 kilogram per meter square STANDARD_DEVIATION 6.3 | 47.6 kilogram per meter square STANDARD_DEVIATION 5.7 |
| CPAP | 9 participants | 10 participants | 19 participants |
| FEV1 (liters) | 2.8 liters STANDARD_DEVIATION 0.6 | 2.9 liters STANDARD_DEVIATION 0.8 | 2.9 liters STANDARD_DEVIATION 0.7 |
| Height (m) | 1.6 centimeters STANDARD_DEVIATION 0.1 | 1.7 centimeters STANDARD_DEVIATION 0.1 | 1.7 centimeters STANDARD_DEVIATION 0.1 |
| Hip circumference (cm) | 136.4 centimeters STANDARD_DEVIATION 11.1 | 142.8 centimeters STANDARD_DEVIATION 14.8 | 139.6 centimeters STANDARD_DEVIATION 13.3 |
| Neck Circumference | 44.9 centimeters STANDARD_DEVIATION 4.8 | 43.9 centimeters STANDARD_DEVIATION 5.9 | 44.4 centimeters STANDARD_DEVIATION 5.3 |
| Region of Enrollment Canada | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
| Sleep apnea Dx (n) | 11 participants | 12 participants | 23 participants |
| Waist circumference (cm) | 113.5 centimeters STANDARD_DEVIATION 14.7 | 138.4 centimeters STANDARD_DEVIATION 15 | 136.1 centimeters STANDARD_DEVIATION 14.7 |
| Waist:hip ratio | 1.0 ratio STANDARD_DEVIATION 0.1 | 1.0 ratio STANDARD_DEVIATION 0.1 | 1.0 ratio STANDARD_DEVIATION 0.1 |
| Weight (kg) | 129 kilogram STANDARD_DEVIATION 20.8 | 131.7 kilogram STANDARD_DEVIATION 11.1 | 130.4 kilogram STANDARD_DEVIATION 10.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Non Hypoxic Apnea Time
Change of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP. End of measure time frame is 5 minutes after intubation
Time frame: After a 3 minutes pre-oxygenation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beach Chair (BC) and ZEEP | Non Hypoxic Apnea Time | 216.7 seconds | Standard Deviation 42.3 |
| Reverse Trendelenburg and NIPPV | Non Hypoxic Apnea Time | 258.2 seconds | Standard Deviation 55.1 |
Hemodynamic Changes
Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode
Time frame: From the beginning of the pre-oxygenation to the end of the protocol
Maximum Expired Fraction of Oxygen Obtained
Evaluation of the maximum expired oxygen fraction obtained in the two groups
Time frame: After 3 minutes of pre-oxygenation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beach Chair (BC) and ZEEP | Maximum Expired Fraction of Oxygen Obtained | 0.89 Maximum expired fraction of oxygen obtai | Standard Deviation 0.01 |
| Reverse Trendelenburg and NIPPV | Maximum Expired Fraction of Oxygen Obtained | 0.91 Maximum expired fraction of oxygen obtai | Standard Deviation 0.01 |
Minimum Arterial Saturation of Oxygen Obtained
Evaluation of the minimal saturation obtained after the resumption of the ventilation
Time frame: After the end of the Non-hypoxic apnea time
Population: One patient missing in the BC group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beach Chair (BC) and ZEEP | Minimum Arterial Saturation of Oxygen Obtained | 83.6 percent | Standard Deviation 0.9 |
| Reverse Trendelenburg and NIPPV | Minimum Arterial Saturation of Oxygen Obtained | 85.3 percent | Standard Deviation 4.5 |
Time to 97% Saturation
Time frame: Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%
Population: 4 values missing in the BC group and 5 values missing in RT group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beach Chair (BC) and ZEEP | Time to 97% Saturation | 88.4 seconds | Standard Deviation 17.3 |
| Reverse Trendelenburg and NIPPV | Time to 97% Saturation | 68 seconds | Standard Deviation 10.6 |
Time to Expired Oxygen Fraction > 0,9
Evaluation of time needed to obtain an expired fraction of oxygen of \> 0,9 in the two groups during the pre-oxygenation
Time frame: During the pre-oxygenation period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beach Chair (BC) and ZEEP | Time to Expired Oxygen Fraction > 0,9 | 145.3 seconds | Standard Deviation 40.8 |
| Reverse Trendelenburg and NIPPV | Time to Expired Oxygen Fraction > 0,9 | 85.1 seconds | Standard Deviation 47.8 |