Intracuff Pressure During One-lung Ventilation in Infants... | NCT02424487

Studies
Intracuff Pressure During One-lung Ventilation in Infants and Children

NCT02424487

Sponsor

Joseph D. Tobias

Status

Completed

Last Update Posted

Jan 18, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

One-lung Ventilation (OLV)

Interventions

Intracuff pressure measurement in one-lung ventilation during thoracic surgery

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

Jan 2019

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

May 2015

Primary Completion Date

Feb 23, 2018Actual

Completion Date

Feb 23, 2018Actual

First Submitted Date

Nov 14, 2014

First Submission Date that Met QC Criteria

Apr 22, 2015

First Posted Date

Apr 23, 2015Estimated

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

Jan 16, 2019

Last Update Posted Date

Jan 18, 2019Actual

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

The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intracuff pressure during one-lung ventilation		Measurement of changes in intracuff pressure with one-lung ventilation during thoracic surgery.	Procedure: Intracuff pressure measurement in one-lung ventilation during thoracic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intracuff pressure measurement in one-lung ventilation during thoracic surgery	Procedure		Intracuff pressure during one-lung ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracuff pressure during OLV	Evaluate changes in intracuff pressure with OLV during thoracic surgery.	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 0-18 yars old.
Patients requiring intubation with a cuffed specialized endotracheal tube or bronchial blocker.
Patients having thoracic surgery.
Patients that require one-lung ventilation (OLV).

Exclusion Criteria:

Patients that do not require to have cuffed specialized endotracheal tube or bronchial blocker.
Patients not requiring one-lung ventilation.
Patients not having thoracic surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Male and female from 0-18 years old having thoracic surgery and requiring one-lung ventilation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Tobias	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States