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

NCT02121808 | Completed Results

• 1 other identifier: IUCPQ 21054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Bariatric Surgery Candidate

Keywords

Morbid Obesity; Bariatric Surgery Candidate; Pre-Oxygenation; Functional Residual Capacity

Outcome Measures

Primary Outcomes (1)

• 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.

  After a 5 minutes pre-oxygenation period

Secondary Outcomes (3)

• Diaphragmatic Amplitude.

  After a 5 minutes pre-oxygenation period

• Respiratory Mechanics

  At the end of a 5 minutes pre-oxygenation period

• Patient's Comfort

  At the end of a 5 minutes pre-oxygenation period

Other Outcomes (1)

• Vital Signs

  At the end of a 5 minutes pre-oxygenation period

Study Arms (3)

Supine

EXPERIMENTAL

NIPPV and Tidal volume

Procedure: NIPPV; Procedure: Tidal volume

Beach-chair (Back : 25 deg)

EXPERIMENTAL

NIPPV and Tidal volume

Procedure: NIPPV; Procedure: Tidal volume

Proclive (Global 25 deg)

EXPERIMENTAL

NIPPV and Tidal volume

Procedure: NIPPV; Procedure: Tidal volume

Interventions

NIPPV PROCEDURE

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)

Beach-chair (Back : 25 deg); Proclive (Global 25 deg); Supine

Tidal volume PROCEDURE

Tidal volume spontaneous ventilation, no assistance.

Beach-chair (Back : 25 deg); Proclive (Global 25 deg); Supine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 40 - 80 kg / m2
• Waist circumference: Men: More than 130 cm
• Waist circumference: Women: More than 115 cm

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (19)

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  PMID: 17122570 BACKGROUND

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  PMID: 12873960 BACKGROUND

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  PMID: 8110546 BACKGROUND

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  PMID: 1984382 BACKGROUND

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  PMID: 9357902 BACKGROUND

• Berthoud MC, Peacock JE, Reilly CS. Effectiveness of preoxygenation in morbidly obese patients. Br J Anaesth. 1991 Oct;67(4):464-6. doi: 10.1093/bja/67.4.464.

  PMID: 1931404 BACKGROUND

• Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.

  PMID: 23836064 BACKGROUND

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  PMID: 19399574 BACKGROUND

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  PMID: 16779465 BACKGROUND

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  PMID: 15915022 BACKGROUND

• Boyce JR, Ness T, Castroman P, Gleysteen JJ. A preliminary study of the optimal anesthesia positioning for the morbidly obese patient. Obes Surg. 2003 Feb;13(1):4-9. doi: 10.1381/096089203321136511.

  PMID: 12630606 BACKGROUND

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  PMID: 8167771 BACKGROUND

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• Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005 Feb;100(2):580-584. doi: 10.1213/01.ANE.0000143339.40385.1B.

  PMID: 15673897 BACKGROUND

• Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b.

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  PMID: 18431116 BACKGROUND

• Couture EJ, Provencher S, Somma J, Lellouche F, Marceau S, Bussieres JS. Effect of position and positive pressure ventilation on functional residual capacity in morbidly obese patients: a randomized trial. Can J Anaesth. 2018 May;65(5):522-528. doi: 10.1007/s12630-018-1050-1. Epub 2018 Jan 18.

  PMID: 29435810 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Jean S. Bussières
• Organization: Laval University

jbuss@criucpq.ulaval.ca

418 656-8711

Study Officials

• Etienne J Couture, MD

  Laval University

  PRINCIPAL INVESTIGATOR

• Jean S Bussières, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2017-09

Locations

CA (1)