Evaluation of V/Q Mismatch as Predictor of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery

Completed

• Conditions: Anesthesia; Postoperative Complications; Mechanical Ventilation Complication
• Interventions: Device: Measure of ventilation/perfusion (V/Q) mismatch using Beacon ALPE (Automatic Lung Paramether Estimator)

• Registration Number: NCT05454917
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

Pulmonary postoperative complications (PPC) are among the main causes of surgical complications affecting both postoperative morbidity and mortality. Little is known about the effect of intraoperative VQ mismatch on the occurrence of PPC. In this trial the investigators will evaluate if intraoperative VQ mismatch may predict PPC in a population of patients undergoing major surgery.

Detailed Description

Pulmonary postoperative complications (PPC) are among the main causes of surgical complications affecting both postoperative morbidity and mortality. Little is known about the effect of intraoperative VQ mismatch on the occurrence of PPC.

PPC are classically considered associated to the occurrence of intraoperative atelectasis, and therefore to the development of a certain amount of shunt, but this concept have been recently questioned.

Recent studies showed indeed that, despite age is one of the main determinants of PPCs, increasing age is not associated to the increase of intraoperative shunt. Shunt therefore may not be the main determinant of PPC.

In this trial the investigators will evaluate if other causes of intraoperative VQ mismatch (e.g. low V/Q, high V/Q, dead space) may predict PPC in a population of patients undergoing major surgery.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Age 18-90 years
• Major elective surgery with general anesthesia
• Intraoperative cannulation of the radial artery for invasive pressure monitoring

Exclusion Criteria

• Thoracic surgery with one lung ventilation
• Refuse to participate
• Emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing surgery	Measure of ventilation/perfusion (V/Q) mismatch using Beacon ALPE (Automatic Lung Paramether Estimator)	Mechanical measures, VQ mismatch evaluation

Primary Outcome Measures

Name	Time	Method
Occurrence of Pulmonary postoperative complications	In the first 7 days after surgery	Definition derived from the ESA-ESICM joined taskforce on perioperative outcome measures.

Secondary Outcome Measures

Name	Time	Method
Intraoperative drug administration	During surgery	Evalation of anesthetic drugs administered during surgery by the treating physician.
fluid balance	During surgery	Evaluation of patients fluid intake and fluid balance during surgery
Intraoperative heart rate	During surgery	evaluation of; - Heart rate (beats/min)
Intraoperative mechanical measures (pressures)	During surgery	Intraoperative evaluation of: * Peak pressure (Ppeak), cmH2O; * Plateau pressure (Pplat), cmH2O; * Total PEEP (PEEP total), cmH2O
V/Q mismatch	During anesthesia	Evaluation of V/Q mismatch
Intraoperative arterial pressure	During surgery	Evaluation during surgery of: * systolic pressure (mmHg); * diastolic pressure (mmHg)

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy