NCT03395782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

January 4, 2018

Last Update Submit

September 29, 2021

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • PaO2 breathing air before start of pre-oxygenation and the rise in end-tidal O2 during pre-oxygenation.

    An arterial bloodgas with the patient in the supine position breathing air will be analysed with regards to PaO2 and correlated to the rise in end-tidal O2 concentration during pre-oxygenation.

    5 minutes.

Secondary Outcomes (1)

  • Age and the rise in end-tidal O2 during pre-oxygenation.

    5 minutes.

Study Arms (4)

Age group 40-49

30 patients will be stratified to this age group.

Age group 50-59

30 patients will be stratified to this age group.

Age group 60-69

30 patients will be stratified to this age group.

Age group 70-79

30 patients will be stratified to this age group.

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective surgery in general anaesthesia.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Köping County Hospital

Köping, Västmanland County, 73130, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 20508794RESULT

  • 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.

    PMID: 19464611RESULT

  • 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.

    PMID: 17237952RESULT

  • 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: 3578856RESULT

  • 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.

    PMID: 37395501DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Arteriell blood-gases.

Study Officials

  • Lennart Edmark, Ph.D.

    Region Västmanland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 10, 2018

Study Start

October 30, 2018

Primary Completion

September 17, 2021

Study Completion

September 29, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)