NCT05345743

Brief 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. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

April 11, 2022

Last Update Submit

July 1, 2024

Conditions

Keywords

AnesthesiaAIR-testPostoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

  • 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

    The first 5 postoperative days

Secondary Outcomes (11)

  • AIR-test result

    Intraoperative period

  • Tidal volume during general anesthesia for surgery

    Intraoperative period

  • Positive End-Expiratory Pressure during general anesthesia for surgery

    Intraoperative period

  • Peak Pressure during general anesthesia for surgery

    Intraoperative period

  • Driving Pressure during general anesthesia for surgery

    Intraoperative period

  • +6 more secondary outcomes

Study Arms (2)

Positive AIR-test

Patients with a positive intraoperative AIR-test result

Procedure: Surgery

Negative AIR-test

Patients with a negative intraoperative AIR-test result

Procedure: Surgery

Interventions

SurgeryPROCEDURE

All types of surgery requiring general anesthesia

Negative AIR-testPositive AIR-test

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing surgery under general anesthesia in whom an AIR test is performed

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years;
  • No consent/objection;
  • Patient participated in another conflicting interventional study on mechanical ventilation during general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Centers

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

  • 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. 2025 Oct 23. doi: 10.1097/EJA.0000000000002304. Online ahead of print.

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Markus W Hollmann, Professor

    Anesthesiology and Pain Medicine, AUMC location AMC

    PRINCIPAL INVESTIGATOR
  • Marcus J Schultz, Professor

    Intensive Care, AUMC location AMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 26, 2022

Study Start

April 21, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations