- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03395782
Factors Determining Oxygen Wash in During Pre-oxygenation
Factors Determining End-tidal O2 Concentration in During Pre-oxygenation
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Västmanland
-
Köping, Västmanland, Sweden, 73130
- Köping County Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PaO2 breathing air before start of pre-oxygenation and the rise in end-tidal O2 during pre-oxygenation.
Time Frame: 5 minutes.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age and the rise in end-tidal O2 during pre-oxygenation.
Time Frame: 5 minutes.
|
Age will be correlated to the rise in end-tidal O2 during pre-oxygenation.
|
5 minutes.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lennart Edmark, Ph.D., Region Västmanland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20170517-184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Airway Complication of Anesthesia
-
Instituto de Investigación Sanitaria de la Fundación...UnknownAirway Complication of Anesthesia | Anesthesia Intubation ComplicationSpain
-
Bezmialem Vakif UniversityCompletedAirway Complication of Anesthesia | Airway Aspiration | Complication of Anesthesia | Esophagus Injury | Supraglottic Airway Efficiency | Endoscopic Ergonomics | ERCP Airway ManagementTurkey
-
Ain Shams UniversityRecruitingAnesthesia | Airway Complication of AnesthesiaEgypt
-
Inonu UniversityCompletedAirway Complication of Anesthesia | Airway AspirationTurkey
-
Universitätsklinikum Hamburg-EppendorfCompletedAirway Management | Anesthesia | Airway Complication of Anesthesia | Intubation;Difficult | LaryngoscopyGermany
-
Baylor College of MedicineRecruiting
-
University of Turin, ItalyNot yet recruitingAirway Complication of AnesthesiaUnited States, India, Italy, France, Ireland
-
Diskapi Yildirim Beyazit Education and Research...RecruitingAirway Complication of AnesthesiaTurkey
-
Aga Khan UniversityRecruiting
-
Samuel Lunenfeld Research Institute, Mount Sinai...CompletedAirway Complication of AnesthesiaCanada