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

Evaluation of Intraoperative V/Q Mismatch and Compliance Trajectories as Predictors of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Azienda Ospedaliero Universitaria Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing general anesthesia for elective major surgery (non-thoracic).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing surgery; Mechanical measures, VQ mismatch evaluation	Device: Measure of ventilation/perfusion (V/Q) mismatch using Beacon ALPE (Automatic Lung Paramether Estimator); Evaluation of intraoperative V/Q mismatch using the Beacon ALPE during anesthesia.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: Aalborg University
• Investigators: Study Director: Savino Spadaro, MD, PhD, Università degli Studi di Ferrara; Principal Investigator: Gaetano Scaramuzzo, MD, Università degli Studi di Ferrara

Publications and helpful links

General Publications

• Hedenstierna G, Tokics L, Scaramuzzo G, Rothen HU, Edmark L, Ohrvik J. Oxygenation Impairment during Anesthesia: Influence of Age and Body Weight. Anesthesiology. 2019 Jul;131(1):46-57. doi: 10.1097/ALN.0000000000002693.
• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002. Review.
• Spadaro S, Grasso S, Karbing DS, Santoro G, Cavallesco G, Maniscalco P, Murgolo F, Di Mussi R, Ragazzi R, Rees SE, Volta CA, Fogagnolo A. Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation. J Clin Monit Comput. 2021 Oct;35(5):1149-1157. doi: 10.1007/s10877-020-00582-z. Epub 2020 Aug 20.
• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Anesthesia; Pulmonary postoperative complications; ALPE; Ventilation/perfusion mismatch
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: VQppc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No