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

NCT02590406 | Completed Results

• 1 other identifier: IUCPQ 21211
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

Morbid Obesity; Bariatric Surgery; Pre-Oxygenation; Anesthesia Induction; Positive pressure ventilation; Non hypoxic apnea time; Positive-Pressure Respiration; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• 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

  After a 3 minutes pre-oxygenation period

Secondary Outcomes (5)

• Time to Expired Oxygen Fraction > 0,9

  During the pre-oxygenation period

• Maximum Expired Fraction of Oxygen Obtained

  After 3 minutes of pre-oxygenation

• Minimum Arterial Saturation of Oxygen Obtained

  After the end of the Non-hypoxic apnea time

• 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

Study Arms (2)

Beach chair (BC) and ZEEP

ACTIVE COMPARATOR

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

Procedure: Beach chair (BC) and ZEEP

Reverse Trendelenburg and NIPPV

EXPERIMENTAL

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

Procedure: Reverse Trendelenburg and NIPPV

Interventions

Beach chair (BC) and ZEEP PROCEDURE

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

Reverse Trendelenburg and NIPPV PROCEDURE

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 40
• Abdominal obesity : waist circumference: \> 115 for the women waist circumference \> 130 for the men

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (21)

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  PMID: 16229689 BACKGROUND

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  PMID: 15527629 BACKGROUND

• Levitan RM, Mechem CC, Ochroch EA, Shofer FS, Hollander JE. Head-elevated laryngoscopy position: improving laryngeal exposure during laryngoscopy by increasing head elevation. Ann Emerg Med. 2003 Mar;41(3):322-30. doi: 10.1067/mem.2003.87.

  PMID: 12605198 BACKGROUND

• Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.

  PMID: 15105237 BACKGROUND

• Cressey DM, Berthoud MC, Reilly CS. Effectiveness of continuous positive airway pressure to enhance pre-oxygenation in morbidly obese women. Anaesthesia. 2001 Jul;56(7):680-4. doi: 10.1046/j.1365-2044.2001.01374-3.x.

  PMID: 11437771 BACKGROUND

• 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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• Baraka AS, Hanna MT, Jabbour SI, Nawfal MF, Sibai AA, Yazbeck VG, Khoury NI, Karam KS. Preoxygenation of pregnant and nonpregnant women in the head-up versus supine position. Anesth Analg. 1992 Nov;75(5):757-9. doi: 10.1213/00000539-199211000-00018.

  PMID: 1416130 BACKGROUND

• Lellouche F, Dionne S, Simard S, Bussieres J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012 May;116(5):1072-82. doi: 10.1097/ALN.0b013e3182522df5.

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• Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009.

  PMID: 15915022 RESULT

• Couture EJ, Carrier-Boucher A, Provencher S, Tanoubi I, Marceau S, Bussieres JS. Effect of reverse Trendelenburg position and positive pressure ventilation on safe non-hypoxic apnea period in obese, a randomized-control trial. BMC Anesthesiol. 2023 Jun 8;23(1):198. doi: 10.1186/s12871-023-02128-7.

  PMID: 37291541 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The main limitation of this study is that we did not compare the position and ventilation mode separately. The reason why we decided to do it as a bundle of interventions was that we wanted to minimize the number of patients exposed to the protocol.

Results Point of Contact

• Title: Dr Jean S Bussières
• Organization: Institut universitaire Cardiologie et Pneumologie de Québec

jbuss@criucpq.ulaval.ca

418-656-8711

Study Officials

• Antony Carrier-Boucher, MD

  Laval University

  PRINCIPAL INVESTIGATOR

• Bussières S Jean, 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: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 29, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 25, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Locations

CA (1)