Clinical trial NCT05454917: Evaluation of V/Q Mismatch as Predictor of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery
Official title: Evaluation of Intraoperative V/Q Mismatch and Compliance Trajectories as Predictors of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Postoperative Complications
Mechanical Ventilation Complication
Keywords: Anesthesia
Pulmonary postoperative complications
ALPE
Ventilation/perfusion mismatch
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-07-12
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia for elective major surgery (non-thoracic).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Pulmonary postoperative complications
timeFrame: In the first 7 days after surgery
Secondary outcomes:
measure: Intraoperative mechanical measures (pressures)
timeFrame: During surgery
measure: Intraoperative drug administration
timeFrame: During surgery
measure: Intraoperative arterial pressure
timeFrame: During surgery
measure: Intraoperative heart rate
timeFrame: During surgery
measure: V/Q mismatch
timeFrame: During anesthesia
measure: fluid balance
timeFrame: During surgery
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
affiliation: Università degli Studi di Ferrara
name: Savino Spadaro, MD, PhD
role: STUDY_DIRECTOR
affiliation: Università degli Studi di Ferrara
name: Gaetano Scaramuzzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
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.
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.