Surgery--ComplicationsNCT05345743
The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia
An observational study of Surgery--Complications and Atelectasis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Surgery--Complications, Atelectasis, Anesthesia
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 632 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Apr 2022to 1 Jun 2024
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing surgery under general anesthesia in whom an AIR test is performed
Who may be able to join
- Patients undergoing surgery under general anesthesia in the Amsterdam University Medical Centers, location Meibergdreef with an Endotracheal Tube;
- Patients > 18 years;
- Preoperative SpO2 of ≥97%;
- AIR-test performed after induction of anesthesia, in a hemodynamic and respiratory steady state.
Who cannot join
- Age < 18 years;
- No consent/objection;
- Patient participated in another conflicting interventional study on mechanical ventilation during general anesthesia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam University Medical Centers
Amsterdam, North Holland, 1105 AZ
About this study
The overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.
Read the detailed description
The 'AIR-test', a method wherein inspiratory oxygen concentration is reduced to 21% and pulse-oximetry hemoglobin saturation (SpO2) is monitored, can be used to demonstrate the presence of an atelectasis-induced alveolar shunt. It remains uncertain whether an intraoperative positive AIR-test is associated with clinical outcomes. It is hypothesized that in a general surgical population, the incidence of postoperative pulmonary complications (PPC) is higher in patients with a positive AIR-test than in patients with a negative AIR-test. The aim of this study is to describe the incidence of PPC in patients with a positive and in patients with a negative AIR-test. Second, the investigators want to describe the incidence of a positive AIR-test and its association with the development of PPC. The investigators also want to evaluate whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.
- Conditions
- Surgery--Complications, Atelectasis, Anesthesia
- Being tested
- Surgery
- Keywords
- Anesthesia, AIR-test, Postoperative Pulmonary Complications
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
All types of surgery requiring general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Positive AIR-test | Patients with a positive intraoperative AIR-test result Receives: Procedure: Surgery | |
| Negative AIR-test | Patients with a negative intraoperative AIR-test result Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pulmonary complications
Respiratory failure; Bronchospasm; Acute Respiratory Distress Syndrome (ARDS); Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax
Measured: The first 5 postoperative days
Secondary outcomes (11)
AIR-test result
Number of patients with a positive and negative AIR-test
Measured: Intraoperative period
Tidal volume during general anesthesia for surgery
Tidal volume in mL per kg predicted bodyweight
Measured: Intraoperative period
Positive End-Expiratory Pressure during general anesthesia for surgery
Positive End-Expiratory Pressure in Centimeters of Water (cmH2O)
Measured: Intraoperative period
Peak Pressure during general anesthesia for surgery
Peak Pressure in cmH20
Measured: Intraoperative period
Driving Pressure during general anesthesia for surgery
Driving Pressure in cmH2O
Measured: Intraoperative period
Fraction of Inspired Oxygen during general anesthesia for surgery
Fraction of Inspired Oxygen
Measured: Intraoperative period
End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery
End-tidal CO2 in millimeters of mercury (mmHg)
Measured: Intraoperative period
Respiratory Rate during general anesthesia for surgery
Respiratory Rate per minute
Measured: Intraoperative period
The incidence of the individual components of postoperative pulmonary complications
Respiratory failure; Bronchospasm; ARDS; Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax
Measured: The first 5 postoperative days
Length of hospital stay
Days of hospital stay
Measured: From the day of surgery until the day of discharge, up to day 30
Rate of all-cause mortality and in-hospital mortality
Mortality rate
Measured: Postoperative day 5 and postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start21 Apr 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- 632 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Amsterdam UMC, location AMC
- Investigators
- Markus W Hollmann, Professor, Principal investigator, Anesthesiology and Pain Medicine, AUMC location AMCMarcus J Schultz, Professor, Principal investigator, Intensive Care, AUMC location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345743
- Sponsor's protocol ID
- W22_079
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hol L, Vermeulen TD, de Kruijk RS, Tjikhoeri A, Koning GRM, Breel JS, van Meenen DMP, Hollmann MW, Schultz MJ. Associations of a positive intra-operative air-test with postoperative pulmonary complications in general surgery patients: A single-centre prospective observational study. Eur J Anaesthesiol. 2026 May 1;43(5):405-414. doi: 10.1097/EJA.0000000000002304. Epub 2025 Oct 22.
PubMed 41222052
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia
- ClinicalTrials.gov ID
- NCT05345743
- Acronym / sponsor ID
- W22_079
- Conditions
- Surgery--Complications, Atelectasis, Anesthesia
- Keywords
- Anesthesia, AIR-test, Postoperative Pulmonary Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 26 Apr 2022 (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.
The overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.
Detailed description
The 'AIR-test', a method wherein inspiratory oxygen concentration is reduced to 21% and pulse-oximetry hemoglobin saturation (SpO2) is monitored, can be used to demonstrate the presence of an atelectasis-induced alveolar shunt. It remains uncertain whether an intraoperative positive AIR-test is associated with clinical outcomes. It is hypothesized that in a general surgical population, the incidence of postoperative pulmonary complications (PPC) is higher in patients with a positive AIR-test than in patients with a negative AIR-test. The aim of this study is to describe the incidence of PPC in patients with a positive and in patients with a negative AIR-test. Second, the investigators want to describe the incidence of a positive AIR-test and its association with the development of PPC. The investigators also want to evaluate whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive AIR-test | – | Procedure: SurgeryPatients with a positive intraoperative AIR-test result |
| Negative AIR-test | – | Procedure: SurgeryPatients with a negative intraoperative AIR-test result |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgery under general anesthesia in whom an AIR test is performed
Key inclusion criteria (4 listed)
- Patients undergoing surgery under general anesthesia in the Amsterdam University Medical Centers, location Meibergdreef with an Endotracheal Tube;
- Patients > 18 years;
- Preoperative SpO2 of ≥97%;
- AIR-test performed after induction of anesthesia, in a hemodynamic and respiratory steady state.
Key exclusion criteria (3 listed)
- Age < 18 years;
- No consent/objection;
- Patient participated in another conflicting interventional study on mechanical ventilation during general anesthesia
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 |
|---|---|---|
| SurgeryAll types of surgery requiring general anesthesia | Procedure or surgery | Negative AIR-test, Positive AIR-test |
Primary outcome
The incidence of postoperative pulmonary complications
Time frame: The first 5 postoperative days
Respiratory failure; Bronchospasm; Acute Respiratory Distress Syndrome (ARDS); Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax
11 secondary outcomes
AIR-test result
Time frame: Intraoperative period
Tidal volume during general anesthesia for surgery
Time frame: Intraoperative period
Positive End-Expiratory Pressure during general anesthesia for surgery
Time frame: Intraoperative period
Peak Pressure during general anesthesia for surgery
Time frame: Intraoperative period
Driving Pressure during general anesthesia for surgery
Time frame: Intraoperative period
Fraction of Inspired Oxygen during general anesthesia for surgery
Time frame: Intraoperative period
End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery
Time frame: Intraoperative period
Respiratory Rate during general anesthesia for surgery
Time frame: Intraoperative period
The incidence of the individual components of postoperative pulmonary complications
Time frame: The first 5 postoperative days
Length of hospital stay
Time frame: From the day of surgery until the day of discharge, up to day 30
Rate of all-cause mortality and in-hospital mortality
Time frame: Postoperative day 5 and postoperative day 30
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 3 Jul 2024.
- Derived from this study: PubMed 41222052Hol L, Vermeulen TD, de Kruijk RS, Tjikhoeri A, Koning GRM, Breel JS, van Meenen DMP, Hollmann MW, Schultz MJ. Associations of a positive intra-operative air-test with postoperative pulmonary complications in general surgery patients: A single-centre prospective observational study. Eur J Anaesthesiol. 2026 May 1;43(5):405-414. doi: 10.1097/EJA.0000000000002304. Epub 2025 Oct 22.
- Individual participant dataSharing planned: Undecided
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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.
Markus W Hollmann, Professor principal investigator
Anesthesiology and Pain Medicine, AUMC location AMC
Marcus J Schultz, Professor principal investigator
Intensive Care, AUMC location AMC
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 Surgery--Complications and Atelectasis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 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 3 Jul 2024. 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 Netherlands. 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?
The incidence of postoperative pulmonary complications (time frame: The first 5 postoperative days). 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 NCT05345743, which also lists 1 linked publication.
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 3 Jul 2024.