Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery

NCT07135492 | Completed

• 1 other identifier: A01890
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Thoracic; surgery; hemoglobin; transcutaneous oximetry.

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  6 Hours

Interventions

continuous noninvasive hemoglobin monitoring DIAGNOSTIC_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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• aged 18 years and older who were subjected to open thoracic surgery
• the length of surgery was ≥ 4 hours

You may not qualify if:

• dysrhythmia
• coagulopathy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ministry of health

Jeddah, Mekkah, 31511, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 26654895 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 22, 2025
• Study Start: July 3, 2024
• Primary Completion: July 3, 2025
• Study Completion: July 4, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)