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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345743
• Other study ID #: W22_079
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Liselotte Hol, MD
• Phone: 020 566 9111
• Email: l.hol[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 632
• Est. completion date: April 1, 2027
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Atelectasis
• Pulmonary Atelectasis
• Surgery--Complications

Intervention

Procedure:
• Surgery
All types of surgery requiring general anesthesia

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

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