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

EPO2-A: Evaluation of Different Pre-Oxygenation Condition in Morbid Obesity: Effect of Position and Positive Pressure Ventilation During General Anesthesia Induction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02590406
Acronym
EPO2-A
Enrollment
50
Registered
2015-10-29
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

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

PROCEDUREBeach 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

PROCEDUREReverse 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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Non Hypoxic Apnea TimeAfter a 3 minutes pre-oxygenation periodChange 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

MeasureTime frameDescription
Time to Expired Oxygen Fraction > 0,9During the pre-oxygenation periodEvaluation 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 ObtainedAfter 3 minutes of pre-oxygenationEvaluation of the maximum expired oxygen fraction obtained in the two groups
Minimum Arterial Saturation of Oxygen ObtainedAfter the end of the Non-hypoxic apnea timeEvaluation of the minimal saturation obtained after the resumption of the ventilation
Time to 97% SaturationEvaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%
Hemodynamic ChangesFrom the beginning of the pre-oxygenation to the end of the protocolEvaluation 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

ArmCount
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
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudySaturometer malfunction01

Baseline characteristics

CharacteristicBeach Chair (BC) and ZEEPReverse Trendelenburg and NIPPVTotal
Age, Continuous46.3 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
CPAP9 participants10 participants19 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 Circumference44.9 centimeters
STANDARD_DEVIATION 4.8
43.9 centimeters
STANDARD_DEVIATION 5.9
44.4 centimeters
STANDARD_DEVIATION 5.3
Region of Enrollment
Canada
24 Participants24 Participants48 Participants
Sex: Female, Male
Female
18 Participants16 Participants34 Participants
Sex: Female, Male
Male
6 Participants8 Participants14 Participants
Sleep apnea Dx (n)11 participants12 participants23 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 ratio1.0 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Beach Chair (BC) and ZEEPNon Hypoxic Apnea Time216.7 secondsStandard Deviation 42.3
Reverse Trendelenburg and NIPPVNon Hypoxic Apnea Time258.2 secondsStandard Deviation 55.1
Comparison: We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.p-value: 0.005ANOVA
Secondary

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

Secondary

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

ArmMeasureValue (MEAN)Dispersion
Beach Chair (BC) and ZEEPMaximum Expired Fraction of Oxygen Obtained0.89 Maximum expired fraction of oxygen obtaiStandard Deviation 0.01
Reverse Trendelenburg and NIPPVMaximum Expired Fraction of Oxygen Obtained0.91 Maximum expired fraction of oxygen obtaiStandard Deviation 0.01
p-value: 0.0003ANOVA
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Beach Chair (BC) and ZEEPMinimum Arterial Saturation of Oxygen Obtained83.6 percentStandard Deviation 0.9
Reverse Trendelenburg and NIPPVMinimum Arterial Saturation of Oxygen Obtained85.3 percentStandard Deviation 4.5
p-value: 0.9ANOVA
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Beach Chair (BC) and ZEEPTime to 97% Saturation88.4 secondsStandard Deviation 17.3
Reverse Trendelenburg and NIPPVTime to 97% Saturation68 secondsStandard Deviation 10.6
p-value: 0.03ANOVA
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Beach Chair (BC) and ZEEPTime to Expired Oxygen Fraction > 0,9145.3 secondsStandard Deviation 40.8
Reverse Trendelenburg and NIPPVTime to Expired Oxygen Fraction > 0,985.1 secondsStandard Deviation 47.8
p-value: <0.0001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026