NCT04740385

Brief Summary

to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

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

February 1, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

February 1, 2021

Last Update Submit

July 16, 2022

Conditions

Diagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position

    real time visulaization of air entry to the lung

    5 minutes

Secondary Outcomes (1)

  • procedural time

    5 minutes

Study Arms (1)

Lung cancer patients

Correct position of double lumen endotracheal tube will be assessed using lung sonography, routine chest auscultation and fiberoptic brochoscopy

Diagnostic Test: Lung auscultationDevice: Fiberoptic bronchoscopyDevice: Lung Ultrasound

Interventions

Lung auscultationDIAGNOSTIC_TEST

auscultation of air entry through chest wal

Lung cancer patients
Fiberoptic bronchoscopyDEVICE

Checking correct double lumen position through direct vision using fiberoptic bronchoscopy

Lung cancer patients
Lung UltrasoundDEVICE

real time visualization of air entry to the lungs using trans-thoracic lung ultrasound

Lung cancer patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lung cancer patients undergoing thoracic surgeries requiring double lumen intubation

You may qualify if:

  • patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation
  • ASA I-II

You may not qualify if:

  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesia and pain medicine. National Cancer Institute

Cairo, 11796, Egypt

Location

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and pain management

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

February 3, 2021

Primary Completion

June 25, 2022

Study Completion

June 30, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)