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Completed

NCT Number: NCT07135492

Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery

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.

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Key information

Conditions

Thoracic Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ministry of health

Jeddah, Mekkah, 31511, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • dysrhythmia
  • coagulopathy

Treatment and study plan

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).

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Acronym: noninvasive Hb

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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