HealthyNCT00922753

Inspiratory Support Improves Preoxygenation in Healthy Subjects

A study testing VS, AI-4/PEEP-4 and AI-6/PEEP-4 in people with Healthy, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: VS, AI-4/PEEP-4 and AI-6/PEEP-4
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCanada
Study dates: Feb 2007to Sep 2007
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers
Aged between 20 to 40 years

Who cannot join

Body mass index > 30
Mustache, beard
Claustrophobia

Trial locations and contacts

1 site in 1 country.

Canada1 site

Maisonneuve Rosemont Hospital
Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

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

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.

Read the 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%.

Conditions: Healthy
Being tested: VS, AI-4/PEEP-4, AI-6/PEEP-4
Keywords: Preoxygenation, Inspiratory, Support, Healthy, EndtidalO2
Medical subject headings: Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00922753
Study group	Role	What they receive
BiPAP6 assisted preoxygenation	Active comparator	Not described Receives: Other: AI-6/PEEP-4
BiPAP4 assisted preoxygenation	Active comparator	Not described Receives: Other: AI-4/PEEP-4
Standard preoxygenation (VS)	Active comparator	Not described Receives: Other: VS

What is being measured

The primary outcome is the main question the study is designed to answer.

expiratory oxygen fraction (end-tidal 02)

Secondary outcomes (8)

inspiratory oxygen fraction
end-tidal CO2
tidal volume
inspiratory pressure
subject's tolerance
leaks around the mask during preoxygenation
minute volume
endexpiratory pressure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Sep 2007

First posted17 Jun 2009 (estimated)
Study startFeb 2007
Primary completionSep 2007
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00922753
Sponsor's protocol ID: 06109
Status last verified: Jun 2009
First submitted: 16 Jun 2009
Last updated: 18 Jun 2009
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 13268902
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.
PubMed 2494907
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.
PubMed 16371614
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.
PubMed 12943861
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.
PubMed 2221412
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.
PubMed 3826588
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.
PubMed 3578856
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.
PubMed 11878698
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.
PubMed 8214545
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.
PubMed 3592155
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.
PubMed 15105237
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.
PubMed 11097548
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.
PubMed 14570682
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.
PubMed 15915022
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.
PubMed 16436870

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Tolerability of Different Levels of Inspiratory Support and PEEP During Preoxygenation. A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT00922753
Acronym / sponsor ID: 06109
Conditions: Healthy
Keywords: Preoxygenation, Inspiratory, Support, Healthy, EndtidalO2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Maisonneuve-Rosemont HospitalUniversity, hospital or other
Study start: Feb 2007
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 17 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy volunteers
Aged between 20 to 40 years

Key exclusion criteria (3 listed)

Body mass index > 30
Mustache, beard
Claustrophobia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VSSpontaneous breathing of 100% oxygen in a facemask for 3 minutes	Other	Standard preoxygenation (VS)
AI-4/PEEP-4Spontaneous 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	Other	BiPAP4 assisted preoxygenation
AI-6/PEEP-4Spontaneous 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.	Other	BiPAP6 assisted preoxygenation

Primary outcome

expiratory oxygen fraction (end-tidal 02)

8 secondary outcomes

inspiratory oxygen fraction
end-tidal CO2
tidal volume
inspiratory pressure
subject's tolerance
leaks around the mask during preoxygenation
minute volume
endexpiratory pressure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2009.
Background: PubMed 13268902HAMILTON 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.
Background: PubMed 2494907Goldberg 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.
Background: PubMed 16371614Gagnon 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.
Background: PubMed 12943861Bourgain 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.
Background: PubMed 2221412Valentine 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.
Background: PubMed 3826588Byrne 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.
Background: PubMed 3578856Gambee 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.
Background: PubMed 11878698Hirsch 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.
Background: PubMed 8214545Machlin 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.
Background: PubMed 3592155Russell 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.
Background: PubMed 15105237Coussa 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.
Background: PubMed 11097548Baraka 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.

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Trained vs. Untrained: Lower Extremity Pressure Changes
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Issam Tanoubi, M.D. principal investigator

Maisonneuve Rosemont Hospital, University Of Montreal

François Donati, PhD, MD, FRCPC study director

Maisonneuve Rosemont Hospital, University Of Montreal

Pierre Drolet, MD, FRCPC study chair

Maisonneuve Rosemont Hospital, University Of Montreal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VS, AI-4/PEEP-4 and AI-6/PEEP-4 in people with Healthy, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

expiratory oxygen fraction (end-tidal 02). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00922753, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2009.