Noninvasive Hemoglobin Monitoring by Spectrophotometry in... | NCT05171296

Studies
Noninvasive Hemoglobin Monitoring by Spectrophotometry in Blunt Abdominal Trauma Patients for Conservative Management

NCT05171296

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jul 21, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Intensive Care Unit

Interventions

Not provided

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2021Actual

Primary Completion Date

Aug 22, 2022Estimated

Completion Date

Aug 22, 2022Estimated

First Submitted Date

Dec 10, 2021

First Submission Date that Met QC Criteria

Dec 10, 2021

First Posted Date

Dec 28, 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 19, 2022

Last Update Posted Date

Jul 21, 2022Actual

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

We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management.

Detailed Description

Not provided

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

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
abdominal trauma patients		blunt abdominal trauma patients planned for conservation.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy of hemoglobin measured by the noninvasive device.	accuracy of hemoglobin measured by the noninvasive hemoglobin test device (Radical-7®; Masimo Corp., Irvine, CA) in comparison with standard CBC that is assayed on Coulter LH 750 Cell Counter (Beckman Coulter Corporation, Florida, USA), using reagents supplied by the company in patients suffering frm blunt abdominal trauma aditted to ICU for observation.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I to III, of either sex, 18 -80 years of age, non-sedated non-intubated patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation.

Exclusion Criteria:

Patients with fever, hypothermia, history of a neurological, psychiatric, dementia or, who are taking psychotropic drugs Patients with unstable hemodynamic status, and unconscious patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr hafez, M.D	Contact	01225674370	002	amr_foud@med.asu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University hospitals	Recruiting	Cairo		11591	Egypt