NCT04865874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

April 14, 2021

Last Update Submit

October 7, 2022

Conditions

Thoracic SurgeryFluid-therapy

Keywords

pulse pressure variationzero balancesingle-lung ventilation

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)

    15 minutes after extubation

Secondary Outcomes (2)

  • Postoperative pulmonary complications

    Up to 3 days after surgery

  • In-hospital stay

    Days until discharge, an average of 5 days

Study Arms (2)

PPV-GDT

EXPERIMENTAL

Intra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%)

Other: PPV-GDT

Zero balance

ACTIVE COMPARATOR

Intra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output

Other: Zero-balance

Interventions

PPV-GDTOTHER

fluid-therapy based on PPV monitoring

PPV-GDT
Zero-balanceOTHER

fluid-therapy based on urinary output balance

Zero balance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio/Rome, 00168, Italy

RECRUITING

Study Officials

  • Paola Aceto, MD,PhD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Aceto, MD,PhD

CONTACT

+390630154507paola.aceto@policlinicogemelli.it

Giovanni Punzo, MD

CONTACT

+390630154507giovanni.punzo@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 29, 2021

Study Start

September 21, 2021

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)