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Early Warning for Desaturation by Oxygen Reserve Index

NCT04976504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2021-07-26

No results posted yet for this study

Summary

During the induction of general anesthesia, the anesthesiologist needs to provide the oxygen supply to meet the patient's needs continuously. In the clinical scenario, the pulse oximeter is used as a standard to monitor hemoglobin oxygen saturation (SpO2) but is limited to assess the oxygenation status beyond the measurement of 100%. The Oxygen Reserve Index (ORi) is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status. This study was designed to evaluate the duration of warning time for desaturation provided by different ORi alarm triggers during prolonged apnea in surgical patients. The primary endpoint was the duration of additional warning time provided by the ORi trigger. The secondary endpoint was the correlation of ORi and PaO2.

Conditions

  • Desaturation of Blood
  • Anesthesia

Interventions

DEVICE

Oxygen reserve index

This is an observational study of the routine clinical practice with no specific additional interventions required. The investigators enrolled the ASA physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. ORi and standard monitors were placed. The patients were preoxygenated and received anesthesia induction as routine clinical practice. Intubation was done by video-laryngoscope. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Hung-Wei Cheng, MD · Taipei Veteran General Hospital, Taiwan

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976504 on ClinicalTrials.gov