Intensive Care UnitNCT05171296
Noninvasive Hemoglobin Monitoring by Spectrophotometry in Blunt Abdominal Trauma Patients for Conservative Management
An observational study of Intensive Care Unit, run by Ain Shams University at 1 site in Egypt.
Trial summary
We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intensive Care Unit
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2021to 22 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation.
Who may be able to join
- 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.
Who cannot join
- Patients with fever, hypothermia, history of a neurological, psychiatric, dementia or, who are taking psychotropic drugs Patients with unstable hemodynamic status, and unconscious patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospitals
Cairo, 11591
Amr Fouad, MD, 01225674370, amr_foud@med.asu.edu.eg
About this study
Official title: 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.
- Conditions
- Intensive Care Unit
- Keywords
- massimo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| abdominal trauma patients | blunt abdominal trauma patients planned for conservation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start22 Nov 2021
- Primary completion22 Aug 2022 (estimated)
- Study completion22 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171296
- Sponsor's protocol ID
- FMASU R 177 / 2021
- Status last verified
- Jul 2022
- First submitted
- 10 Dec 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Hemoglobin Monitoring by Spectrophotometry (SpHb) in Blunt Abdominal Trauma Patients for Conservative Management
- ClinicalTrials.gov ID
- NCT05171296
- Acronym / sponsor ID
- FMASU R 177 / 2021
- Conditions
- Intensive Care Unit
- Keywords
- massimo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 22 Aug 2022 (estimated)
- Study completion
- 22 Aug 2022 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal trauma patients | – | –blunt abdominal trauma patients planned for conservation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will be admitted to Ain Shams university hospital - surgical intensive care unit, after blunt abdominal trauma planned for conservation.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with fever, hypothermia, history of a neurological, psychiatric, dementia or, who are taking psychotropic drugs Patients with unstable hemodynamic status, and unconscious patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
Related trials for Intensive Care Unit
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr hafez, M.D (01225674370 ext. 002, amr_foud@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of hemoglobin measured by the noninvasive device. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.