Efficiency of Preoxygenation in Obese Patients: Pressure Assisted Versus Traditional Method

NCT00673634 | Completed

• 1 other identifier: 07122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate whether pre-oxygenation of obese patients with BiPAP 4cm H2O, renders any benefit to the quality of pre-oxygenation measured by the expired oxygen fraction (FeO2) and whether it is as well tolerated as the traditional method of spontaneous breathing for 3 minutes.

Conditions

Obesity

Keywords

preoxygenation; method; efficiency; obesity; BiPAP; FeO2

Outcome Measures

Primary Outcomes (1)

• rate of increase of fractional expired oxygen level

  every 10 seconds during each 3 minute preoxygenation period

Secondary Outcomes (1)

• Level of fractional expired oxygen. Patient tolerance. Ease of preoxygenation administration. Presence of secondary effects (gastric reflux, respiratory discomfort, burps)

  every minute during each 3 minute preoxygenation trial and at the end of each trial

Study Arms (2)

1

ACTIVE COMPARATOR

Standard preoxygenation

Procedure: Standard preoxygenation

2

ACTIVE COMPARATOR

BiPAP assisted preoxygenation

Procedure: BiPAP assisted preoxygenation

Interventions

Standard preoxygenation PROCEDURE

Spontaneous breathing of 100% oxygen in a facemask for 3 minutes.

1

BiPAP assisted preoxygenation PROCEDURE

Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4cm H2O and a positive end-expiratory pressure of 4cm H2O, for 3 minutes.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 30
• Scheduled for surgery

You may not qualify if:

• Non fasted patient
• Clinically significant gastro-oesophageal reflux
• Intestinal occlusion
• Presence of nasogastric tube
• Facial hair
• Claustrophobia

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (17)

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  PMID: 13268902 BACKGROUND

• Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.

  PMID: 8110546 BACKGROUND

• 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 BACKGROUND

• Wax DB. Mechanism of benefit of head-up preoxygenation in obese patients. Anesthesiology. 2006 Feb;104(2):381; author reply 381. doi: 10.1097/00000542-200602000-00035. No abstract available.

  PMID: 16436870 BACKGROUND

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  PMID: 10551570 BACKGROUND

• Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786.

  PMID: 16779465 BACKGROUND

• Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93. doi: 10.1213/00000539-199101000-00016.

  PMID: 1984382 BACKGROUND

• Goldberg ME, Norris MC, Larijani GE, Marr AT, Seltzer JL. Preoxygenation in the morbidly obese: a comparison of two techniques. Anesth Analg. 1989 Apr;68(4):520-2. No abstract available.

  PMID: 2494907 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

• Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.

  PMID: 12456460 BACKGROUND

• Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. doi: 10.1007/BF03009858.

  PMID: 8055603 BACKGROUND

• Gagnon C, Fortier LP, Donati F. When a leak is unavoidable, preoxygenation is equally ineffective with vital capacity or tidal volume breathing. Can J Anaesth. 2006 Jan;53(1):86-91. doi: 10.1007/BF03021532.

  PMID: 16371614 BACKGROUND

• Ho-Tai LM, Devitt JH, Noel AG, O'Donnell MP. Gas leak and gastric insufflation during controlled ventilation: face mask versus laryngeal mask airway. Can J Anaesth. 1998 Mar;45(3):206-11. doi: 10.1007/BF03012903.

  PMID: 9579256 BACKGROUND

• Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.

  PMID: 16627862 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

• Kashyap L, Yaddanapudi LN, Sandhya. Arterial desaturation during induction with and without preoxygenation: evaluation of four techniques. Anaesth Intensive Care. 1993 Dec;21(6):811-3. doi: 10.1177/0310057X9302100611.

  PMID: 8122739 BACKGROUND

• Rapaport S, Joannes-Boyau O, Bazin R, Janvier G. [Comparison of eight deep breaths and tidal volume breathing preoxygenation techniques in morbid obese patients]. Ann Fr Anesth Reanim. 2004 Dec;23(12):1155-9. doi: 10.1016/j.annfar.2004.10.012. French.

  PMID: 15589355 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre Drolet, MD, FRCPC

  Maisonneuve-Rosemont Hospital

  STUDY DIRECTOR

• Mihai L Georgescu, MD, resident

  Maisonneuve-Rosemont Hospital / Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 12, 2008

Record last verified: 2008-05

Locations

CA (1)