Inspiratory Support Improves Preoxygenation in Healthy Subjects

Healthy Clinical Trial

Official title:

The Efficacy and Tolerability of Different Levels of Inspiratory Support and PEEP During Preoxygenation. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922753
• Other study ID #: 06109
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: June 17, 2009
• Start date: February 2007
• Est. completion date: September 2007

Study information

• Verified date: June 2009
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Aged between 20 to 40 years

Exclusion Criteria:

• Body mass index > 30

• Mustache, beard

• Claustrophobia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy
• Respiratory Aspiration

Intervention

Other:
• VS
Spontaneous breathing of 100% oxygen in a facemask for 3 minutes
• 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
• 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.

Locations

Country	Name	City	State
Canada	Maisonneuve Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (17)

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

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. — View Citation

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. — View Citation

HAMILTON WK, EASTWOOD DW. A study of denitrogenation with some inhalation anesthetic systems. Anesthesiology. 1955 Nov;16(6):861-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Wax DB. Mechanism of benefit of head-up preoxygenation in obese patients. Anesthesiology. 2006 Feb;104(2):381; author reply 381. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expiratory oxygen fraction (end-tidal 02)			Yes
Secondary	inspiratory oxygen fraction			Yes
Secondary	end-tidal CO2			Yes
Secondary	tidal volume			Yes
Secondary	inspiratory pressure			Yes
Secondary	subject's tolerance			Yes
Secondary	leaks around the mask during preoxygenation			Yes
Secondary	minute volume			Yes
Secondary	endexpiratory pressure			Yes