Height-based Formula for Predicting the Insertion Depth o... | NCT04449770

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

NCT04449770

Sponsor

King Saud University

Status

Unknown status

Last Update Posted

Jul 10, 2020Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Thoracic Anesthesia

Interventions

double lumen tube

Countries

Saudi Arabia

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 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Jun 23, 2020

First Submission Date that Met QC Criteria

Jun 23, 2020

First Posted Date

Jun 29, 2020Actual

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 8, 2020

Last Update Posted Date

Jul 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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.

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

70Estimated

Name	Type	Description	Arm Group Labels	Other Names
double lumen tube	Device	prospective cohort study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients whose procedure required placement of an LDLT

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abdelazeem eldawlatly	Contact	00966503261042		dawlatly2@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Saud University	Recruiting	Riyadh		11462	Saudi Arabia

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