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

NCT ID: NCT05454917

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Postoperative Complications Mechanical Ventilation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing surgery

Mechanical measures, VQ mismatch evaluation

Measure of ventilation/perfusion (V/Q) mismatch using Beacon ALPE (Automatic Lung Paramether Estimator)

Intervention Type DEVICE

Evaluation of intraoperative V/Q mismatch using the Beacon ALPE during anesthesia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aalborg University

OTHER

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Savino Spadaro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Savino Spadaro, MD, PhD

Role: STUDY_DIRECTOR

Università degli Studi di Ferrara

Gaetano Scaramuzzo, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31045901 (View on PubMed)

Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

Reference Type BACKGROUND
PMID: 28186222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32816177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25058504 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VQppc

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OUT-OF-HOSPITAL CPAP STUDY
NCT00439075 COMPLETED PHASE4