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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04865874
Other study ID # 3901
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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