Anesthesia Clinical Trial
Official title:
The Incidence of Postoperative Pulmonary Complications in Patients With a Positive and Negative AIR-Test During General Anesthesia
NCT number | NCT05345743 |
Other study ID # | W22_079 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 21, 2022 |
Est. completion date | April 1, 2027 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Centers | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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 |
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