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Completed

NCT Number: NCT05345743

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

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.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centers

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

All types of surgery requiring general anesthesia

Primary outcomes

  1. 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

  1. AIR-test result

    Time frame: Intraoperative period

    Number of patients with a positive and negative AIR-test

  2. Tidal volume during general anesthesia for surgery

    Time frame: Intraoperative period

    Tidal volume in mL per kg predicted bodyweight

  3. Positive End-Expiratory Pressure during general anesthesia for surgery

    Time frame: Intraoperative period

    Positive End-Expiratory Pressure in Centimeters of Water (cmH2O)

  4. Peak Pressure during general anesthesia for surgery

    Time frame: Intraoperative period

    Peak Pressure in cmH20

  5. Driving Pressure during general anesthesia for surgery

    Time frame: Intraoperative period

    Driving Pressure in cmH2O

  6. Fraction of Inspired Oxygen during general anesthesia for surgery

    Time frame: Intraoperative period

    Fraction of Inspired Oxygen

  7. End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery

    Time frame: Intraoperative period

    End-tidal CO2 in millimeters of mercury (mmHg)

  8. Respiratory Rate during general anesthesia for surgery

    Time frame: Intraoperative period

    Respiratory Rate per minute

  9. The incidence of the individual components of postoperative pulmonary complications

    Time frame: The first 5 postoperative days

    Respiratory failure; Bronchospasm; ARDS; Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax

  10. Length of hospital stay

    Time frame: From the day of surgery until the day of discharge, up to day 30

    Days of hospital stay

  11. Rate of all-cause mortality and in-hospital mortality

    Time frame: Postoperative day 5 and postoperative day 30

    Mortality rate

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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