NCT04988711

Brief Summary

The development of miniaturized analytical technologies has facilitated the gradual decentralization of part of the laboratory examinations to the patient. In addition, investigators are currently seeing the development of tools for non-invasive measurement of certain biological parameters. Thanks to their ease of use, results are obtained almost immediately and with good performance. These "rapid" tests or techniques should, in theory, reduce the time taken to take charge of patients, particularly in emergencies or in critical situations where the therapeutic decision should be as rapid and efficient as possible. These means, by their ease and speed of results, could be associated with the clinical examination of the practitioner to increase his diagnostic performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

3.7 years

First QC Date

May 28, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Accuracy

    The accuracy of Hb Oxymeter

    during the intervention

  • the impact Hb Oxymeter

    the impact Hb Oxymeter

    during the intervention

Study Arms (1)

Hb Oxymeter

EXPERIMENTAL

Hb mesurment

Diagnostic Test: Hb Oxymeter

Interventions

Hb OxymeterDIAGNOSTIC_TEST

Measurement of Hb Oximeter

Hb Oxymeter

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe trauma patients
  • Patients having benefited from a blood sample to measure hemoglobin.

You may not qualify if:

  • Patients less than 3 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

Location

Riadh Boukef

Sahloul, Sousse Governorate, Tunisia

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Riadh Boukef, professor

    CHU Sahloul, Sousse, Tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: descriptive
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

August 3, 2021

Study Start

August 1, 2017

Primary Completion

April 30, 2021

Study Completion

May 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

all data will be presented in the article publication

Locations