Airway Complication of AnesthesiaNCT03395782
Factors Determining Oxygen Wash in During Pre-oxygenation
An observational study of Airway Complication of Anesthesia, run by Region Västmanland at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Airway Complication of Anesthesia
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 30 Oct 2018to 29 Sep 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 40 to 79 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for elective surgery in general anaesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Determining End-tidal O2 Concentration in During Pre-oxygenation
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.
Read the 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.
- Conditions
- Airway Complication of Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes.
Secondary outcomes (1)
Age and the rise in end-tidal O2 during pre-oxygenation.
Age will be correlated to the rise in end-tidal O2 during pre-oxygenation.
Measured: 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start30 Oct 2018
- Primary completion17 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Edmark, Region Västmanland
- Investigators
- Lennart Edmark, Ph.D., Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395782
- Sponsor's protocol ID
- 20170517-184
- Status last verified
- Sep 2021
- First submitted
- 4 Jan 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20508794Sum 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.
PubMed 19464611Milic-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.
PubMed 17237952Gambee 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 3578856Larsson 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.
PubMed 37395501
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Determining End-tidal O2 Concentration in During Pre-oxygenation
- ClinicalTrials.gov ID
- NCT03395782
- Acronym / sponsor ID
- 20170517-184
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 10 Jan 2018 (actual)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery in general anaesthesia.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Age and the rise in end-tidal O2 during pre-oxygenation.
Time frame: 5 minutes.
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 30 Sep 2021.
- Results publication: PubMed 20508794Kang 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.
- Results publication: PubMed 19464611Sum 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.
- Results publication: PubMed 17237952Milic-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.
- Results publication: 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.
- Derived from this study: PubMed 37395501Larsson 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.
- Individual participant dataSharing planned: No
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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.
Lennart Edmark, Ph.D. principal investigator
Region Västmanland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia, run by Region Västmanland at 1 site in Sweden.
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 3 inclusion and 12 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 30 Sep 2021. 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 Sweden. 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?
PaO2 breathing air before start of pre-oxygenation and the rise in end-tidal O2 during pre-oxygenation. (time frame: 5 minutes.). 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 NCT03395782, which also lists 5 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 30 Sep 2021.