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GDT-PPV Protocol in Thoracic Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04865874
Enrollment
88
Registered
2021-04-29
Start date
2021-09-21
Completion date
2023-06-30
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid-therapy, Thoracic Surgery

Keywords

pulse pressure variation, zero balance, single-lung ventilation

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.

Interventions

OTHERPPV-GDT

fluid-therapy based on PPV monitoring

OTHERZero-balance

fluid-therapy based on urinary output balance

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FiO2 ratio15 minutes after extubationRatio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)

Secondary

MeasureTime frameDescription
Postoperative pulmonary complicationsUp to 3 days after surgerye.g. Atelectasis, pneumonia, lung edema, pleural effusion, hypoxemia
In-hospital stayDays until discharge, an average of 5 daysHospital stay duration

Countries

Italy

Contacts

Primary ContactPaola Aceto, MD,PhD
paola.aceto@policlinicogemelli.it+390630154507
Backup ContactGiovanni Punzo, MD
giovanni.punzo@policlinicogemelli.it+390630154507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026