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

Anesthesia Clinical Trial

— VQppc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454917
• Other study ID #: VQppc
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Mechanical Ventilation Complication
• Postoperative Complications

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