Factors Determining Oxygen Wash in During Pre-oxygenation

NCT ID: NCT03395782

Last Updated: 2021-09-30

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

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-30

Study Completion Date

2021-09-29

Brief Summary

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Earlier studies has shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation. In this study the investigators aim to analyse this correlation more closely and investigate if the arterial partial pressure of oxygen (PaO2) as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation.

Detailed Description

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Before induction of general anaesthesia pre-oxygenation is a recommended procedure to enhance the time available for solving a problem with the airway or intubation during induction. This can be accomplished by letting the patient breath normal tidal volumes with 100% oxygen for 3 to 5 minutes during pre-oxygenation. If there is airway closure during tidal volume breathing, pre-oxygenation needs longer time to achieve a maximum effect. Airway closure increases with advanced age and a few earlier studies has also shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation.

Pre-oxygenation is a strongly recommended safety procedure before starting anaesthesia but has at least one major side affect: it is the main reason for the development of atelectasis in the lungs during anaesthesia. Atelectasis impairs oxygenation during anaesthesia and probably increase the risk for postoperative pulmonary complications.

Postoperative complications are more common with advanced age and it is important to understand the mechanisms and risk factors involved.

In this study, the investigators hypothesise that the PaO2 as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation. If this assumption is correct it might have implication for how pre-oxygenation should be adjusted with advancing age.

Conditions

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Airway Complication of Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Age group 40-49

30 patients will be stratified to this age group.

No interventions assigned to this group

Age group 50-59

30 patients will be stratified to this age group.

No interventions assigned to this group

Age group 60-69

30 patients will be stratified to this age group.

No interventions assigned to this group

Age group 70-79

30 patients will be stratified to this age group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for general anaesthesia in American Society of Anesthesiology (ASA) physical status classification grade I-III.
* Body mass index over 18.5 and less than 30 kg/m2
* Peripheral oxygen saturation 92% or more on air.

Exclusion Criteria

* ASA IV.
* Patients with active smoking and former smokers with a history of smoking more than 6 pack-years.
* Chronic obstructive lung disease.
* Bloodgas with PaO2 ≤ 8 kilopascal (kPa) or PaCO2 ≥ 6.5 kPa.
* Continuous positive airway pressure treatment at night.
* Heart failure or angina pectoris.
* Hemoglobin value less than 100 g/L.
* Pregnancy.
* Any neuromuscular or neurologic illness reducing ventilatory capacity.
* Any endocrine disease influencing basic metabolic demand.
* Not possible to achieve a tight mask seal.
* Patient unable to follow instructions.
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Västmanland

OTHER

Sponsor Role lead

Responsible Party

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Lennart Edmark

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lennart Edmark, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Region Västmanland

Locations

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Köping County Hospital

Köping, Västmanland County, Sweden

Site Status

Countries

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Sweden

References

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Kang H, Park HJ, Baek SK, Choi J, Park SJ. Effects of preoxygenation with the three minutes tidal volume breathing technique in the elderly. Korean J Anesthesiol. 2010 Apr;58(4):369-73. doi: 10.4097/kjae.2010.58.4.369. Epub 2010 Apr 28.

Reference Type RESULT
PMID: 20508794 (View on PubMed)

Sum Ping SJ, Makary LF, Van Hal MD. Factors influencing oxygen store during denitrogenation in the healthy patient. J Clin Anesth. 2009 May;21(3):183-9. doi: 10.1016/j.jclinane.2008.07.004.

Reference Type RESULT
PMID: 19464611 (View on PubMed)

Milic-Emili J, Torchio R, D'Angelo E. Closing volume: a reappraisal (1967-2007). Eur J Appl Physiol. 2007 Apr;99(6):567-83. doi: 10.1007/s00421-006-0389-0. Epub 2007 Jan 20.

Reference Type RESULT
PMID: 17237952 (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 RESULT
PMID: 3578856 (View on PubMed)

Larsson A, Ostberg E, Edmark L. Arterial partial pressure of oxygen as a marker of airway closure does not correlate with the efficacy of pre-oxygenation: A prospective cohort study. Eur J Anaesthesiol. 2023 Sep 1;40(9):699-706. doi: 10.1097/EJA.0000000000001869. Epub 2023 Jun 30.

Reference Type DERIVED
PMID: 37395501 (View on PubMed)

Other Identifiers

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20170517-184

Identifier Type: -

Identifier Source: org_study_id

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