PneumothoraxNCT03567759
Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax
An observational study of Pneumothorax, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Esophageal Pressure During one lung ventilation Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumothorax
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2016to 1 Aug 2017
- 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 85 years
- All sexes
- Adult, Older adult
Study population: patients of age 18-85 years scheduled for VATS requiring one lung ventilation
Who may be able to join
- patients scheduled for VATS requiring one lung ventilation
- Body mass index below 35 kg/m^2
Who cannot join
- esophageal pathology preventing insertion of orogatric tube
- scoliosys
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure
Esophageal Pressure During one lung ventilation
Read the detailed description
Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax
- Conditions
- Pneumothorax
- Medical subject headings
- Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in esophageal pressure
esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax
Measured: from tracheal intubation untill fiveminutes after induction of open pneumothorax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Mar 2016
- Primary completion1 Sep 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
- Investigators
- Amit Lehavi, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567759
- Sponsor's protocol ID
- RMB 15-0262
- Status last verified
- Jun 2018
- First submitted
- 13 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure
- ClinicalTrials.gov ID
- NCT03567759
- Acronym / sponsor ID
- RMB 15-0262
- Conditions
- Pneumothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 26 Jun 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.
Esophageal Pressure During one lung ventilation
Detailed description
Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients of age 18-85 years scheduled for VATS requiring one lung ventilation
Key inclusion criteria (2 listed)
- patients scheduled for VATS requiring one lung ventilation
- Body mass index below 35 kg/m^2
Key exclusion criteria (2 listed)
- esophageal pathology preventing insertion of orogatric tube
- scoliosys
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
Changes in esophageal pressure
Time frame: from tracheal intubation untill fiveminutes after induction of open pneumothorax
esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
Related trials for Pneumothorax
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Not yet recruitingObservational study
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Pneumothorax, Intestinal Obstruction
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.
Amit Lehavi, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Rambam Health Care Campus at 1 site in Israel.
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 2 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: finished, as of the sponsor's last update on 26 Jun 2018. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in esophageal pressure (time frame: from tracheal intubation untill fiveminutes after induction of open pneumothorax). 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 26 Jun 2018.