Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy

July 8, 2020 updated by: A.Eldawlatly, King Saud University

A Study on the Use of an Established Novel Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy

The use of height based formula to predict insertion depth of left-sided double lumen tube in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study we are going to use with FOB checking if needed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of a height-based formula to predict the insertion depth of left-sided double-lumen tubes in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study will use FOB checking if needed.

Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That doesn't mean FOB is less required.

Study Type

Observational

Enrollment (Anticipated)

70

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11462
        • Recruiting
        • King Saud University
        • Contact:

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 20-60 yr undergoing thoracic surgery with the use of left-sided DLT for lung isolation

Description

Inclusion Criteria:

  • patients whose procedure required placement of an LDLT

Exclusion Criteria:

  • patients with intraluminal bronchial lesions and patients with a difficult airway.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correct position of DLT with proper lung deflation without use of FOB
Time Frame: during surgical time
proper lung deflation, surgeon satisfaction
during surgical time

Collaborators and Investigators

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

Sponsor

King Saud University

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 (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-18-3064/IRB 06.05.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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