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Clinical Trials/NCT05345743
NCT05345743
Completed
Not Applicable

The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country632 target enrollmentApril 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery--Complications
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
632
Locations
1
Primary Endpoint
The incidence of postoperative pulmonary complications
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2022
End Date
June 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Marcus J. Schultz

Prof. Dr.

Amsterdam UMC, location AMC

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • AIR-test result(Intraoperative period)
  • Tidal volume during general anesthesia for surgery(Intraoperative period)
  • Peak Pressure during general anesthesia for surgery(Intraoperative period)
  • Respiratory Rate during general anesthesia for surgery(Intraoperative period)
  • Fraction of Inspired Oxygen during general anesthesia for surgery(Intraoperative period)
  • Positive End-Expiratory Pressure during general anesthesia for surgery(Intraoperative period)
  • Driving Pressure during general anesthesia for surgery(Intraoperative period)
  • The incidence of the individual components of postoperative pulmonary complications(The first 5 postoperative days)
  • Length of hospital stay(From the day of surgery until the day of discharge, up to day 30)
  • Rate of all-cause mortality and in-hospital mortality(Postoperative day 5 and postoperative day 30)
  • End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery(Intraoperative period)

Study Sites (1)

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