Thoracic SurgeryNCT04865874
GDT-PPV Protocol in Thoracic Surgery
A study testing PPV-GDT and Zero-balance in people with Thoracic Surgery and Fluid-therapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Fluid-therapy
- What is being tested?
- PPV-GDT and Zero-balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 21 Sep 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio/Rome, 00168
Paola Aceto, MD, 00390630154507, paola.aceto@policlinicogemelli.it
About this study
Official title: Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery
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.
Read more
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.
Read the 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.
- Conditions
- Thoracic Surgery, Fluid-therapy
- Being tested
- PPV-GDT, Zero-balance
- Keywords
- pulse pressure variation, zero balance, single-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV-GDTOther
fluid-therapy based on PPV monitoring
Zero-balanceOther
fluid-therapy based on urinary output balance
| Study group | Role | What they receive |
|---|---|---|
| PPV-GDT | Experimental | Intra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%) Receives: Other: PPV-GDT |
| Zero balance | Active comparator | Intra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output Receives: Other: Zero-balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)
Measured: 15 minutes after extubation
Secondary outcomes (2)
Postoperative pulmonary complications
e.g. Atelectasis, pneumonia, lung edema, pleural effusion, hypoxemia
Measured: Up to 3 days after surgery
In-hospital stay
Hospital stay duration
Measured: Days until discharge, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start21 Sep 2021
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Aceto, MD,PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865874
- Sponsor's protocol ID
- 3901
- Status last verified
- Oct 2022
- First submitted
- 14 Apr 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04865874
- Acronym / sponsor ID
- 3901
- Conditions
- Thoracic Surgery, Fluid-therapy
- Keywords
- pulse pressure variation, zero balance, single-lung ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PPV-GDT | Experimental | Other: PPV-GDTIntra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%) |
| Zero balance | Active comparator | Other: Zero-balanceIntra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPV-GDTfluid-therapy based on PPV monitoring | Other | PPV-GDT |
| Zero-balancefluid-therapy based on urinary output balance | Other | Zero balance |
Primary outcome
PaO2/FiO2 ratio
Time frame: 15 minutes after extubation
Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2)
2 secondary outcomes
Postoperative pulmonary complications
Time frame: Up to 3 days after surgery
In-hospital stay
Time frame: Days until discharge, an average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Aceto, MD,PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPV-GDT and Zero-balance in people with Thoracic Surgery and Fluid-therapy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Aceto, MD,PhD (+390630154507, paola.aceto@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: 15 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.