Thoracic Anesthesianoninvasive HbNCT07135492
Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery
An observational study of Thoracic Anesthesia, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
This study investigates the correlation between noninvasive hemoglobin monitoring (SpHb) and invasive hemoglobin measurement (InvHb) in guiding blood transfusions during thoracic surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Anesthesia
- What is being tested?
- continuous noninvasive hemoglobin monitoring
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Jul 2024to 4 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were monitored using ASA standard monitors, along with invasive arterial and/or central venous monitoring as part of their standard care.
Who may be able to join
- aged 18 years and older who were subjected to open thoracic surgery
- the length of surgery was ≥ 4 hours
Who cannot join
- dysrhythmia
- coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the correlation between noninvasive hemoglobin monitoring (SpHb) and invasive hemoglobin measurement (InvHb) in guiding blood transfusions during thoracic surgeries.
Methods: A non-interventional design was used to evaluate the relationship between SpHb and InvHb readings in the context of transfusion decisions. Data were obtained from 80 patients aged 18 years or older undergoing thoracic procedures. Continuous SpHb monitoring was performed, and concurrent InvHb samples were collected for comparison. The primary endpoint was the degree of correlation between SpHb and InvHb values.
- Conditions
- Thoracic Anesthesia
- Being tested
- continuous noninvasive hemoglobin monitoring
- Keywords
- Thoracic, surgery, hemoglobin, transcutaneous oximetry.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous noninvasive hemoglobin monitoringDiagnostic test
noninvasive hemoglobin monitoring, Rainbow® Adult ReSposable™ sensors (Rev E) were placed on either the ring or middle fingertip of each participant and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corp., Irvine, CA).
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between continuous hemoglobin and inasive hemoglubin at the preoperative period
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin 1 hour after start of surgery
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin 2 hours after start of surgery
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin 3 hours after start of surgery
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin 4 hours after start of surgery
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin at the end of surgery
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
the correlation between continuous hemoglobin and inasive hemoglubin after recovery of the patient
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).
invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Measured: 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Jul 2024
- Primary completion3 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135492
- Sponsor's protocol ID
- A01890
- Acronym
- noninvasive Hb
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joseph B, Haider A, Rhee P. Non-invasive hemoglobin monitoring. Int J Surg. 2016 Sep;33(Pt B):254-257. doi: 10.1016/j.ijsu.2015.11.048. Epub 2015 Nov 30.
PubMed 26654895
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07135492
- Acronym / sponsor ID
- noninvasive Hb / A01890
- Conditions
- Thoracic Anesthesia
- Keywords
- Thoracic, surgery, hemoglobin, transcutaneous oximetry.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 22 Aug 2025 (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.
This study investigates the correlation between noninvasive hemoglobin monitoring (SpHb) and invasive hemoglobin measurement (InvHb) in guiding blood transfusions during thoracic surgeries.
Methods: A non-interventional design was used to evaluate the relationship between SpHb and InvHb readings in the context of transfusion decisions. Data were obtained from 80 patients aged 18 years or older undergoing thoracic procedures. Continuous SpHb monitoring was performed, and concurrent InvHb samples were collected for comparison. The primary endpoint was the degree of correlation between SpHb and InvHb values.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were monitored using ASA standard monitors, along with invasive arterial and/or central venous monitoring as part of their standard care.
Key inclusion criteria (2 listed)
- aged 18 years and older who were subjected to open thoracic surgery
- the length of surgery was ≥ 4 hours
Key exclusion criteria (2 listed)
- dysrhythmia
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous noninvasive hemoglobin monitoringnoninvasive hemoglobin monitoring, Rainbow® Adult ReSposable™ sensors (Rev E) were placed on either the ring or middle fingertip of each participant and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corp., Irvine, CA). | Diagnostic test | – |
Primary outcome
the correlation between continuous hemoglobin and inasive hemoglubin at the preoperative period
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin 1 hour after start of surgery
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin 2 hours after start of surgery
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin 3 hours after start of surgery
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin 4 hours after start of surgery
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin at the end of surgery
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
the correlation between continuous hemoglobin and inasive hemoglubin after recovery of the patient
Time frame: 6 Hours
continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA). invasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 26654895Joseph B, Haider A, Rhee P. Non-invasive hemoglobin monitoring. Int J Surg. 2016 Sep;33(Pt B):254-257. doi: 10.1016/j.ijsu.2015.11.048. Epub 2015 Nov 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic Anesthesia, run by Tanta University at 1 site in Saudi Arabia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Aug 2025. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between continuous hemoglobin and inasive hemoglubin at the preoperative period (time frame: 6 Hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07135492, which also lists 1 linked publication.
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 22 Aug 2025.