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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05454917
Other study ID # VQppc
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date May 31, 2022

Study information

Verified date July 2022
Source Università degli Studi di Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Azienda Ospedaliero Universitaria Sant'Anna Ferrara

Sponsors (2)

Lead Sponsor Collaborator
Università degli Studi di Ferrara Aalborg University

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Hedenstierna G, Tokics L, Scaramuzzo G, Rothen HU, Edmark L, Öhrvik J. Oxygenation Impairment during Anesthesia: Influence of Age and Body Weight. Anesthesiology. 2019 Jul;131(1):46-57. doi: 10.1097/ALN.0000000000002693. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

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