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NCT Number: NCT05454917

Evaluation of V/Q Mismatch as Predictor 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.

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Key information

Conditions

Anesthesia Mechanical Ventilation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Occurrence of Pulmonary postoperative complications

    Time frame: In the first 7 days after surgery

    Definition derived from the ESA-ESICM joined taskforce on perioperative outcome measures.

Secondary outcomes

  1. Intraoperative mechanical measures (pressures)

    Time frame: During surgery

    Intraoperative evaluation of:

    • Peak pressure (Ppeak), cmH2O
    • Plateau pressure (Pplat), cmH2O
    • Total PEEP (PEEP total), cmH2O

  2. Intraoperative drug administration

    Time frame: During surgery

    Evalation of anesthetic drugs administered during surgery by the treating physician.

  3. Intraoperative arterial pressure

    Time frame: During surgery

    Evaluation during surgery of:

    • systolic pressure (mmHg)
    • diastolic pressure (mmHg)

  4. Intraoperative heart rate

    Time frame: During surgery

    evaluation of

    • Heart rate (beats/min)

  5. V/Q mismatch

    Time frame: During anesthesia

    Evaluation of V/Q mismatch

  6. fluid balance

    Time frame: During surgery

    Evaluation of patients fluid intake and fluid balance during surgery

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Acronym: VQppc

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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