Intracuff Pressure During One-lung Ventilation in Infants and Children

January 16, 2019 updated by: Joseph D. Tobias
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph D. Tobias

Investigators

  • Principal Investigator: Joseph Tobias, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 23, 2018

Study Completion (Actual)

February 23, 2018

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB14-00826

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on One-lung Ventilation (OLV)

Clinical Trials on Intracuff pressure measurement in one-lung ventilation during thoracic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe