NCT02424487

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

November 14, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

November 14, 2014

Last Update Submit

January 16, 2019

Conditions

One-lung Ventilation (OLV)

Keywords

Initial pressurechanges of intracuff pressureinfants and children

Outcome Measures

Primary Outcomes (1)

  • Intracuff pressure during OLV

    Evaluate changes in intracuff pressure with OLV during thoracic surgery.

    intraoperative

Study Arms (1)

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

Intracuff pressure measurement in one-lung ventilation during thoracic surgeryPROCEDURE
Intracuff pressure during one-lung ventilation

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Joseph Tobias

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman of department

Study Record Dates

First Submitted

November 14, 2014

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

US(1)