NCT00922753

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

7 months

First QC Date

June 16, 2009

Last Update Submit

June 17, 2009

Conditions

Healthy

Keywords

PreoxygenationInspiratorySupportHealthyEndtidalO2

Outcome Measures

Primary Outcomes (1)

  • expiratory oxygen fraction (end-tidal 02)

Secondary Outcomes (8)

  • inspiratory oxygen fraction

  • end-tidal CO2

  • tidal volume

  • inspiratory pressure

  • subject's tolerance

  • +3 more secondary outcomes

Study Arms (3)

BiPAP6 assisted preoxygenation

ACTIVE COMPARATOR
Other: AI-6/PEEP-4

BiPAP4 assisted preoxygenation

ACTIVE COMPARATOR
Other: AI-4/PEEP-4

Standard preoxygenation (VS)

ACTIVE COMPARATOR
Other: VS

Interventions

VSOTHER

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

Standard preoxygenation (VS)
AI-4/PEEP-4OTHER

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

BiPAP4 assisted preoxygenation
AI-6/PEEP-4OTHER

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.

BiPAP6 assisted preoxygenation

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Aged between 20 to 40 years

You may not qualify if:

  • Body mass index \> 30
  • Mustache, beard
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (17)

  • HAMILTON WK, EASTWOOD DW. A study of denitrogenation with some inhalation anesthetic systems. Anesthesiology. 1955 Nov;16(6):861-7. doi: 10.1097/00000542-195511000-00004. No abstract available.

    PMID: 13268902BACKGROUND

  • 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: 2494907BACKGROUND

  • 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: 16371614BACKGROUND

  • 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.

    PMID: 12943861BACKGROUND

  • Valentine SJ, Marjot R, Monk CR. Preoxygenation in the elderly: a comparison of the four-maximal-breath and three-minute techniques. Anesth Analg. 1990 Nov;71(5):516-9. doi: 10.1213/00000539-199011000-00011.

    PMID: 2221412BACKGROUND

  • 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.

    PMID: 3826588BACKGROUND

  • 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.

    PMID: 3578856BACKGROUND

  • 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.

    PMID: 11878698BACKGROUND

  • 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.

    PMID: 8214545BACKGROUND

  • 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.

    PMID: 3592155BACKGROUND

  • 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: 15105237BACKGROUND

  • 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.

    PMID: 11097548BACKGROUND

  • 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.

    PMID: 14570682BACKGROUND

  • 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: 15915022BACKGROUND

  • 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: 16436870BACKGROUND

  • 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.

    PMID: 10551570BACKGROUND

  • 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: 1931404BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Issam Tanoubi, M.D.

    Maisonneuve Rosemont Hospital, University Of Montreal

    PRINCIPAL INVESTIGATOR

  • François Donati, PhD, MD, FRCPC

    Maisonneuve Rosemont Hospital, University Of Montreal

    STUDY DIRECTOR

  • Pierre Drolet, MD, FRCPC

    Maisonneuve Rosemont Hospital, University Of Montreal

    STUDY CHAIR

  • Louis Phillipe Fortier, MSc, MD, FRCPC

    Maisonneuve Rosemont Hospital, University Of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

February 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

CA(1)