Ventilator-Induced Lung InjuryNCT03746236
Transpulmonary Pressure Under Stressing Conditions
An observational study of Ventilator-Induced Lung Injury, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial summary
Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilator-Induced Lung Injury
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Nov 2018to 30 Dec 2019
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent laparoscopic or robotic assisted radical prostatectomy
Who may be able to join
- ASA (american society of anesthesiologists) score ≤ III
- Patients underwent laparoscopic prostatectomy
Who cannot join
- BMI (body mass index) ≥ 30
- Impossibility to insert nasogastric tube
- Anatomic rib cage alterations
Trial locations and contacts
2 sites in 1 country.
Ester Forastiere, chief contact
Italy2 sites, 2 recruiting
- Recruiting
Regina Elena National Cancer Institute
Rome, Rm, 00153
Ester Forastiere, 00390652662994, ester.forastiere@ifo.gov.it
- Recruiting
Regina Elena National Cancer Institute
Rome, 00154
Ester Forastiere, chief
About this study
Official title: Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg
Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.
- Conditions
- Ventilator-Induced Lung Injury
- Medical subject headings
- Ventilator-Induced Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative acute complications
Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization
Measured: 24 hours
Dosage of inflammatory mediators
Dosage of metalloproteinase and interleukin 8 in bronchoaspiration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start14 Nov 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Induced Lung InjuryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746236
- Sponsor's protocol ID
- RS1138/18
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Covotta M, Claroni C, Torregiani G, Menga LS, Venti E, Gazze G, Anzellotti GM, Ceccarelli V, Gaglioti P, Orlando S, Rosa T, Forastiere E, Antonelli M, Grieco DL. Recruitment-to-inflation ratio to assess response to PEEP during laparoscopic surgery: A physiologic study. J Clin Anesth. 2024 Nov;98:111569. doi: 10.1016/j.jclinane.2024.111569. Epub 2024 Aug 5.
PubMed 39106592
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg
- ClinicalTrials.gov ID
- NCT03746236
- Acronym / sponsor ID
- RS1138/18
- Conditions
- Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 19 Nov 2018 (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.
Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent laparoscopic or robotic assisted radical prostatectomy
Key inclusion criteria (2 listed)
- ASA (american society of anesthesiologists) score ≤ III
- Patients underwent laparoscopic prostatectomy
Key exclusion criteria (3 listed)
- BMI (body mass index) ≥ 30
- Impossibility to insert nasogastric tube
- Anatomic rib cage alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative acute complications
Time frame: 24 hours
Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization
Dosage of inflammatory mediators
Time frame: 24 hours
Dosage of metalloproteinase and interleukin 8 in bronchoaspiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 39106592Covotta M, Claroni C, Torregiani G, Menga LS, Venti E, Gazze G, Anzellotti GM, Ceccarelli V, Gaglioti P, Orlando S, Rosa T, Forastiere E, Antonelli M, Grieco DL. Recruitment-to-inflation ratio to assess response to PEEP during laparoscopic surgery: A physiologic study. J Clin Anesth. 2024 Nov;98:111569. doi: 10.1016/j.jclinane.2024.111569. Epub 2024 Aug 5.
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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.
Ester Forastiere, chief contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Induced Lung Injury, run by Regina Elena Cancer Institute at 2 sites 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 2 inclusion and 3 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ester Forastiere, chief (ester.forastiere@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative acute complications (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746236, which also lists 1 linked publication.
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 11 Sep 2019; AzTrials last refreshed its copy on 26 Oct 2026.