NCT03567759

Brief Summary

Esophageal Pressure During one lung ventilation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 13, 2018

Last Update Submit

June 13, 2018

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • Changes in esophageal pressure

    esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax

    from tracheal intubation untill fiveminutes after induction of open pneumothorax

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of age 18-85 years scheduled for VATS requiring one lung ventilation

You may qualify if:

  • patients scheduled for VATS requiring one lung ventilation
  • Body mass index below 35 kg/m\^2

You may not qualify if:

  • esophageal pathology preventing insertion of orogatric tube
  • scoliosys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Amit Lehavi, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Anesthesia

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 26, 2018

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

August 1, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

IL(1)