Clinical trial NCT04865874: GDT-PPV Protocol in Thoracic Surgery
Official title: Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery
Fluid-therapy
Keywords: pulse pressure variation
zero balance
single-lung ventilation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 15 minutes after extubation
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Up to 3 days after surgery
measure: In-hospital stay
timeFrame: Days until discharge, an average of 5 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Lazio/Rome
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Paola Aceto, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: