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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02121808
Acronym
EPO2-PV
Enrollment
20
Registered
2014-04-24
Start date
2014-04-30
Completion date
2014-07-31
Last updated
2018-04-09

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

Conditions

Bariatric Surgery Candidate, Morbid Obesity

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

PROCEDURENIPPV

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)

PROCEDURETidal volume

Tidal volume spontaneous ventilation, no assistance.

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Functional Residual CapacityAfter a 5 minutes pre-oxygenation periodChange 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

MeasureTime frameDescription
Diaphragmatic Amplitude.After a 5 minutes pre-oxygenation periodEvaluation 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 MechanicsAt the end of a 5 minutes pre-oxygenation periodChange 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 ComfortAt the end of a 5 minutes pre-oxygenation periodEvaluation 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

MeasureTime frameDescription
Vital SignsAt the end of a 5 minutes pre-oxygenation periodChange 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

ArmCount
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
Total17

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyTechnical problem3

Baseline characteristics

CharacteristicPosition and Spontaneous vs Pressure Support
Age, Continuous40 years
STANDARD_DEVIATION 9.7
BMI50 kg/m2
STANDARD_DEVIATION 8
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
5 Participants
Waist circumference143 cm
STANDARD_DEVIATION 17

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 17
serious
Total, serious adverse events
0 / 17

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
1. Supine + NIPPVFunctional Residual Capacity2573 mlStandard Deviation 515
2. Supine + Tidal Volume Spontaneous VentilationFunctional Residual Capacity2145 mlStandard Deviation 438
3. Beach Chair (Back 25 Deg) + NIPPVFunctional Residual Capacity2456 mlStandard Deviation 442
4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous VentilFunctional Residual Capacity2219 mlStandard Deviation 477
5. Proclive (Global 25 Deg) + NIPPVFunctional Residual Capacity2684 mlStandard Deviation 473
6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous VentilaFunctional Residual Capacity2282 mlStandard Deviation 501
Secondary

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

Secondary

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

Secondary

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

Other Pre-specified

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

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026