One Lung Ventilation | NCT01997073

Studies
One Lung Ventilation

NCT01997073

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Evaluate the Changes in Respiratory Heat Content During One Lung Ventilation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Mar 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 21, 2013

First Posted Date

Nov 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Specific Aims: 1) Measure exhalation enthalpy in patients receiving conventional positive pressure ventilation during stable hemodynamic conditions. 2) Measure exhalation enthalpy in patients following change from two-lung ventilation to one-lung ventilation while minute ventilation remains constant.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of One-Lung Ventilation on Respiratory Gas Heat Content	Changes in respiratory heat content during one-lung ventilation.	One year.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for elective surgical procedures requiring one lung ventilation.

Exclusion Criteria:

Age <18 years. Pregnancy. Prisoners. Planned pneumoperitoneum.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neal W. Fleming, M.D., Ph.D.	Professor, Director, Cardiovascular and Thoracic Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Health System		Sacramento	California	95817	United States