GDT-PPV Protocol in Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865874
• Other study ID #: 3901
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Paola Aceto, MD,PhD
• Phone: +390630154507
• Email: paola.aceto[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Thoracic Surgery

Intervention

Other:
• PPV-GDT
fluid-therapy based on PPV monitoring
• Zero-balance
fluid-therapy based on urinary output balance

Locations

Country	Name	City	State
Italy	UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome	Lazio/Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)	15 minutes after extubation
Secondary	Postoperative pulmonary complications	e.g. Atelectasis, pneumonia, lung edema, pleural effusion, hypoxemia	Up to 3 days after surgery
Secondary	In-hospital stay	Hospital stay duration	Days until discharge, an average of 5 days