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

Completed

• Conditions: Surgery--Complications; Atelectasis; Anesthesia
• Interventions: Procedure: Surgery

• Registration Number: NCT05345743
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study Start: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-26
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 632

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Positive AIR-test	Surgery	Patients with a positive intraoperative AIR-test result
Negative AIR-test	Surgery	Patients with a negative intraoperative AIR-test result

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative pulmonary complications	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 Outcome Measures

Name	Time	Method
AIR-test result	Intraoperative period	Number of patients with a positive and negative AIR-test
Tidal volume during general anesthesia for surgery	Intraoperative period	Tidal volume in mL per kg predicted bodyweight
Peak Pressure during general anesthesia for surgery	Intraoperative period	Peak Pressure in cmH20
Respiratory Rate during general anesthesia for surgery	Intraoperative period	Respiratory Rate per minute
Fraction of Inspired Oxygen during general anesthesia for surgery	Intraoperative period	Fraction of Inspired Oxygen
Positive End-Expiratory Pressure during general anesthesia for surgery	Intraoperative period	Positive End-Expiratory Pressure in Centimeters of Water (cmH2O)
Driving Pressure during general anesthesia for surgery	Intraoperative period	Driving Pressure in cmH2O
The incidence of the individual components of postoperative pulmonary complications	The first 5 postoperative days	Respiratory failure; Bronchospasm; ARDS; Suspected pulmonary infection; Aspiration pneumonitis; Atelectasis; Pleural effusion; Pulmonary infiltrate; Cardiopulmonary effusion; Pneumothorax
Length of hospital stay	From the day of surgery until the day of discharge, up to day 30	Days of hospital stay
Rate of all-cause mortality and in-hospital mortality	Postoperative day 5 and postoperative day 30	Mortality rate
End-tidal Carbon Dioxide (CO2) during general anesthesia for surgery	Intraoperative period	End-tidal CO2 in millimeters of mercury (mmHg)

Trial Locations

Locations (1)

Amsterdam University Medical Centers; 🇳🇱 Amsterdam, Noord-Holland, Netherlands