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

July 19, 2022 updated by: Ain Shams University

Noninvasive Hemoglobin Monitoring by Spectrophotometry (SpHb) in Blunt Abdominal Trauma Patients for Conservative Management

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Recruiting
        • Ain shams university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
abdominal trauma patients
blunt abdominal trauma patients planned for conservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of hemoglobin measured by the noninvasive device.
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Anticipated)

August 22, 2022

Study Completion (Anticipated)

August 22, 2022

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 177 / 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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