NCT05454917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

July 4, 2022

Last Update Submit

July 8, 2022

Conditions

AnesthesiaPostoperative ComplicationsMechanical Ventilation Complication

Keywords

AnesthesiaPulmonary postoperative complicationsALPEVentilation/perfusion mismatch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Intraoperative mechanical measures (pressures)

    During surgery

  • Intraoperative drug administration

    During surgery

  • Intraoperative arterial pressure

    During surgery

  • Intraoperative heart rate

    During surgery

  • V/Q mismatch

    During anesthesia

  • +1 more secondary outcomes

Study Arms (1)

Patients undergoing surgery

Mechanical measures, VQ mismatch evaluation

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

Interventions

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

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

Patients undergoing surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Location

Related Publications (4)

  • 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.

    PMID: 31045901BACKGROUND

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

    PMID: 28186222BACKGROUND

  • 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.

    PMID: 32816177BACKGROUND

  • 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.

    PMID: 25058504BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsRespiratory Aspiration

Interventions

Perfusion

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Savino Spadaro, MD, PhD

    Università degli Studi di Ferrara

    STUDY DIRECTOR

  • Gaetano Scaramuzzo, MD

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 12, 2022

Study Start

January 1, 2019

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

IT(1)