Clinical trial NCT05345743: The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia
Official title: The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Atelectasis
Anesthesia
Keywords: Anesthesia
AIR-test
Postoperative Pulmonary Complications
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing surgery under general anesthesia in whom an AIR test is performed

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.

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

Primary outcomes:
measure: The incidence of postoperative pulmonary complications
timeFrame: The first 5 postoperative days
Secondary outcomes:
measure: AIR-test result
timeFrame: Intraoperative period
measure: Tidal volume during general anesthesia for surgery
timeFrame: Intraoperative period
measure: Positive End-Expiratory Pressure during general anesthesia for surgery
timeFrame: Intraoperative period
measure: Peak Pressure during general anesthesia for surgery
timeFrame: Intraoperative period
measure: Driving Pressure during general anesthesia for surgery
timeFrame: Intraoperative period
measure: Fraction of Inspired Oxygen during general anesthesia for surgery
timeFrame: Intraoperative period
measure: End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery
timeFrame: Intraoperative period
measure: Respiratory Rate during general anesthesia for surgery
timeFrame: Intraoperative period
measure: The incidence of the individual components of postoperative pulmonary complications
timeFrame: The first 5 postoperative days
measure: Length of hospital stay
timeFrame: From the day of surgery until the day of discharge, up to day 30
measure: Rate of all-cause mortality and in-hospital mortality
timeFrame: Postoperative day 5 and postoperative day 30
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
state: Noord-Holland
Study officials:
affiliation: Anesthesiology and Pain Medicine, AUMC location AMC
name: Markus W Hollmann, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensive Care, AUMC location AMC
name: Marcus J Schultz, Professor
role: PRINCIPAL_INVESTIGATOR
References: