Use of Ulna Length to Predict Tidal Volume in Adult Egypt... | NCT04644458

Studies
Use of Ulna Length to Predict Tidal Volume in Adult Egyptians

NCT04644458

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Sep 28, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Tidal Volume

Interventions

Measuring the ulna length using meauring tape

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

Sep 2021

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

Oct 20, 2020Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Nov 15, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 25, 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

Sep 26, 2021

Last Update Posted Date

Sep 28, 2021Actual

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

The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.

Detailed Description

After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:

PBW= 50*0.91 (centimetres of height - 152.4) in males and 45.5*0.91(centimetres of height - 152.4) in females.

Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measuring the ulna length using meauring tape	Other	the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Protective lung tidal volume		measurement of left ulna while standing for each volunteer throught the study completion, average 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Healthy adult Egyptian

Exclusion Criteria:

- Deformity or previous surgery in the left arm

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Adult Egyptian volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bahaa M Refaie, MD	Contact	01026887257		bahaarefaay@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
Hosam eldeen M Marie, MD	Consultant of anesthesia and ICU Elhelal insurance hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university hospital	Recruiting	Sohag			Egypt