Role of Lung Ultrasound in Confirmation of Correct Double... | NCT04740385

Studies
Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries

NCT04740385

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

Jul 19, 2022Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Diagnostic Accuracy

Interventions

Lung auscultation
Fiberoptic bronchoscopy
Lung Ultrasound

Countries

Egypt

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

Jul 2022

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

Feb 3, 2021Actual

Primary Completion Date

Jun 25, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Feb 1, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 5, 2021Actual

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

Jul 16, 2022

Last Update Posted Date

Jul 19, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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

Detailed Description

Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy then lung ultrasound. After double lumen intubation all patient tube position will be confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound

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

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 auscultation Device: Fiberoptic bronchoscopy Device: Lung Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung auscultation	Diagnostic Test	auscultation of air entry through chest wal	Lung cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
procedural time	time taken to confirm tube position	5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patient refusal
patients not meeting the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

lung cancer patients undergoing thoracic surgeries requiring double lumen intubation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of anesthesia and pain medicine. National Cancer Institute		Cairo		11796	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided