GDT-PPV Protocol in Thoracic Surgery

Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery

Peri-operative fluid-therapy is extremely important in thoracic surgery, because excessive administration of fluids during one-lung ventilation is correlated to an increasing risk of postoperative respiratory complications.

Therefore, current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy, based on intra-operative fluid loss replacement and maintenance of euvolemia.

Nevertheless, intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice, and this often prevents the euvolemia maintenance in the peri-operative period.

This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery; among these the most promising is the "Goal-Directed Therapy" (GDT). GDT protocols based on Stroke Volume Variation (SVV) or Pulse Pressure Variation (PPV) monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery.

The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative "zero-balance" protocol on intrapulmonary gas exchanges, in patients undergoing single-lung ventilation during thoracic surgery.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Fluid-therapy
• Intervention / Treatment: Other: PPV-GDT; Other: Zero-balance

Detailed Description

The intra-operative fluid-therapy (using lactated Ringer) will be based on pulse pressure variation (PPV group) with a target ≤5.8% or on compensation (1:1) of urine output (zero balance group).

In both groups an intraoperative background infusion of lactated Ringer at 1-2 ml/kg/h will be administered.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paola Aceto, MD,PhD; Phone Number: +390630154507; Email: paola.aceto@policlinicogemelli.it
• Study Contact Backup: Name: Giovanni Punzo, MD; Phone Number: +390630154507; Email: giovanni.punzo@policlinicogemelli.it

Study Locations

• Italy
  • Lazio/Rome
    • Rome, Lazio/Rome, Italy, 00168
      • Recruiting
      • UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy

Exclusion Criteria:

• Patients who will not sign the informed consent
• Obesity (BMI > 35 kg/m2)
• Cardiovascular disease (heart failure, arrhythmia)
• OSAS requiring or not C-PAP therapy
• Chronic alcoholism
• intraoperative blod loss> 1500 ml
• One-lung ventilation duration< 60 min

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PPV-GDT; Intra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%)	Other: PPV-GDT; fluid-therapy based on PPV monitoring
ACTIVE_COMPARATOR: Zero balance; Intra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output	Other: Zero-balance; fluid-therapy based on urinary output balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio	Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)	15 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pulmonary complications	e.g. Atelectasis, pneumonia, lung edema, pleural effusion, hypoxemia	Up to 3 days after surgery
In-hospital stay	Hospital stay duration	Days until discharge, an average of 5 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Paola Aceto, MD,PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: pulse pressure variation; zero balance; single-lung ventilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 3901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No