Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
88 participants
INTERVENTIONAL
2021-09-21
2023-06-30
Brief Summary
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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.
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Detailed Description
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In both groups an intraoperative background infusion of lactated Ringer at 1-2 ml/kg/h will be administered.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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PPV-GDT
Intra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%)
PPV-GDT
fluid-therapy based on PPV monitoring
Zero balance
Intra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output
Zero-balance
fluid-therapy based on urinary output balance
Interventions
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PPV-GDT
fluid-therapy based on PPV monitoring
Zero-balance
fluid-therapy based on urinary output balance
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Paola Aceto, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
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UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio/Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3901
Identifier Type: -
Identifier Source: org_study_id
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