Inspiratory Support Improves Preoxygenation in Healthy Subjects

NCT ID: NCT00922753

Last Updated: 2009-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-09-30

Brief Summary

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Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate preoxygenation is defined by an expiratory oxygen fraction (FEO2) \> 90%. Inspiratory support and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to evaluate the efficacy and tolerability of different levels of inspiratory support and positive end expiratory pressure during preoxygenation in healthy subjects.

Detailed Description

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We conducted a double blind prospective randomized trial on 20 healthy volunteers. Each subject went through three modes of preoxygenation in random order: normal breathing (SP), breathing under inspiratory support 4 cmH2O/PEEP 4 cmH2O (PSM-4) and inspiratory support 6 cmH2O /PEEP 4 cmH2O (PSM-6). Each mode lasted for 3 min and parameters were recorded every 10 s. We evaluated subject's tolerance, leaks and easiness of each mode of preoxygenation according to a simplified (1 to 4) scale. Two-way ANOVA was used to compare FEO2 while simple ANOVA was used for time to reach FEO2=90%.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BiPAP6 assisted preoxygenation

Group Type ACTIVE_COMPARATOR

AI-6/PEEP-4

Intervention Type OTHER

Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.

BiPAP4 assisted preoxygenation

Group Type ACTIVE_COMPARATOR

AI-4/PEEP-4

Intervention Type OTHER

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

Standard preoxygenation (VS)

Group Type ACTIVE_COMPARATOR

VS

Intervention Type OTHER

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

Interventions

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VS

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

Intervention Type OTHER

AI-4/PEEP-4

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

Intervention Type OTHER

AI-6/PEEP-4

Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Aged between 20 to 40 years

Exclusion Criteria

* Body mass index \> 30
* Mustache, beard
* Claustrophobia
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maisonneuve-Rosemont Hospital, Department Of Anesthesiology

Principal Investigators

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Issam Tanoubi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve Rosemont Hospital, University Of Montreal

François Donati, PhD, MD, FRCPC

Role: STUDY_DIRECTOR

Maisonneuve Rosemont Hospital, University Of Montreal

Pierre Drolet, MD, FRCPC

Role: STUDY_CHAIR

Maisonneuve Rosemont Hospital, University Of Montreal

Louis Phillipe Fortier, MSc, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve Rosemont Hospital, University Of Montreal

Locations

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Maisonneuve Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Reference Type BACKGROUND
PMID: 13268902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2494907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16371614 (View on PubMed)

Bourgain JL. [Preoxygenation and upper airway patency control]. Ann Fr Anesth Reanim. 2003 Aug;22 Suppl 1:41s-52s. doi: 10.1016/s0750-7658(03)00125-4. French.

Reference Type BACKGROUND
PMID: 12943861 (View on PubMed)

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Reference Type BACKGROUND
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Byrne F, Oduro-Dominah A, Kipling R. The effect of pregnancy on pulmonary nitrogen washout. A study of pre-oxygenation. Anaesthesia. 1987 Feb;42(2):148-50. doi: 10.1111/j.1365-2044.1987.tb02987.x.

Reference Type BACKGROUND
PMID: 3826588 (View on PubMed)

Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. No abstract available.

Reference Type BACKGROUND
PMID: 3578856 (View on PubMed)

Hirsch J, Fuhrer I, Kuhly P, Schaffartzik W. Preoxygenation: a comparison of three different breathing systems. Br J Anaesth. 2001 Dec;87(6):928-31. doi: 10.1093/bja/87.6.928.

Reference Type BACKGROUND
PMID: 11878698 (View on PubMed)

Machlin HA, Myles PS, Berry CB, Butler PJ, Story DA, Heath BJ. End-tidal oxygen measurement compared with patient factor assessment for determining preoxygenation time. Anaesth Intensive Care. 1993 Aug;21(4):409-13. doi: 10.1177/0310057X9302100406.

Reference Type BACKGROUND
PMID: 8214545 (View on PubMed)

Russell GN, Smith CL, Snowdon SL, Bryson TH. Pre-oxygenation and the parturient patient. Anaesthesia. 1987 Apr;42(4):346-51. doi: 10.1111/j.1365-2044.1987.tb03972.x.

Reference Type BACKGROUND
PMID: 3592155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15105237 (View on PubMed)

Baraka A, Haroun-Bizri S, Khoury S, Chehab IR. Single vital capacity breath for preoxygenation. Can J Anaesth. 2000 Nov;47(11):1144-6. doi: 10.1007/BF03027970.

Reference Type BACKGROUND
PMID: 11097548 (View on PubMed)

Baraka AS, Taha SK, El-Khatib MF, Massouh FM, Jabbour DG, Alameddine MM. Oxygenation using tidal volume breathing after maximal exhalation. Anesth Analg. 2003 Nov;97(5):1533-1535. doi: 10.1213/01.ANE.0000082528.93345.B9.

Reference Type BACKGROUND
PMID: 14570682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15915022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16436870 (View on PubMed)

Pelosi P, Ravagnan I, Giurati G, Panigada M, Bottino N, Tredici S, Eccher G, Gattinoni L. Positive end-expiratory pressure improves respiratory function in obese but not in normal subjects during anesthesia and paralysis. Anesthesiology. 1999 Nov;91(5):1221-31. doi: 10.1097/00000542-199911000-00011.

Reference Type BACKGROUND
PMID: 10551570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1931404 (View on PubMed)

Other Identifiers

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06109

Identifier Type: -

Identifier Source: org_study_id

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