Inspiratory Support Improves Preoxygenation in Healthy Subjects - Full Text View

Purpose

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.

Condition	Intervention
Healthy	Other: VS Other: AI-4/PEEP-4 Other: AI-6/PEEP-4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	The Efficacy and Tolerability of Different Levels of Inspiratory Support and PEEP During Preoxygenation. A Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:

expiratory oxygen fraction (end-tidal 02) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

inspiratory oxygen fraction [ Designated as safety issue: Yes ]
end-tidal CO2 [ Designated as safety issue: Yes ]
tidal volume [ Designated as safety issue: Yes ]
inspiratory pressure [ Designated as safety issue: Yes ]
subject's tolerance [ Designated as safety issue: Yes ]
leaks around the mask during preoxygenation [ Designated as safety issue: Yes ]
minute volume [ Designated as safety issue: Yes ]
endexpiratory pressure [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	February 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: BiPAP6 assisted preoxygenation	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.
Active Comparator: BiPAP4 assisted preoxygenation	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
Active Comparator: Standard preoxygenation (VS)	Other: VS Spontaneous breathing of 100% oxygen in a facemask for 3 minutes

Detailed Description:

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%.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers
Aged between 20 to 40 years

Exclusion Criteria:

Body mass index > 30
Mustache, beard
Claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922753

Locations

Canada, Quebec
Maisonneuve Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4

Sponsors and Collaborators

Maisonneuve-Rosemont Hospital

Investigators

Principal Investigator:	Issam Tanoubi, M.D.	Maisonneuve Rosemont Hospital, University Of Montreal
Study Director:	François Donati, PhD, MD, FRCPC	Maisonneuve Rosemont Hospital, University Of Montreal
Study Chair:	Pierre Drolet, MD, FRCPC	Maisonneuve Rosemont Hospital, University Of Montreal
Principal Investigator:	Louis Phillipe Fortier, MSc, MD, FRCPC	Maisonneuve Rosemont Hospital, University Of Montreal

More Information

Additional Information:

Oxygenation before anesthesia (preoxygenation) in adults This link exits the ClinicalTrials.gov site

Publications:

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

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.

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.

Bourgain JL. [Preoxygenation and upper airway patency control] Ann Fr Anesth Reanim. 2003 Aug;22 Suppl 1:41s-52s. Review. French.

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.

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.

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.

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

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.

Russell GN, Smith CL, Snowdon SL, Bryson TH. Pre-oxygenation and the parturient patient. Anaesthesia. 1987 Apr;42(4):346-51.

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.

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

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):1533-5.

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.

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

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.

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

Responsible Party:	Tanoubi Issam, M.D., Maisonneuve-Rosemont Hospital, Department Of Anesthesiology
ClinicalTrials.gov Identifier:	NCT00922753 History of Changes
Other Study ID Numbers:	06109
Study First Received:	June 16, 2009
Last Updated:	June 17, 2009
Health Authority:	Canada: Health Canada Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee

Keywords provided by Maisonneuve-Rosemont Hospital:

Preoxygenation
Inspiratory
Support
Healthy
EndtidalO2

Additional relevant MeSH terms:

Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013