Desaturation of BloodNCT04976504
Early Warning for Desaturation by Oxygen Reserve Index
An observational study of Desaturation of Blood and Anesthesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Desaturation of Blood, Anesthesia
- What is being tested?
- Oxygen reserve index
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 30 Oct 2019
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia and did not match the exclusion criteria.
Who may be able to join
- Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia.
Who cannot join
- Age <18 years
- Inability to give primary consent
- Pregnancy
- History of chronic obstructive pulmonary disease (COPD)
- History of asthma
- Suspected difficult intubation
- Preoperative hemoglobin less than 10 mg/dl.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Early Warning for Desaturation by Oxygen Reserve Index During Induction of General Anesthesia
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.
Read the detailed description
This is an observational study of the routine clinical practice with no specific additional interventions required.
The investigators enrolled the American Society of Anesthesiologists (ASA) physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. Patients were positioned supine on the operating room table. Standard monitors and the ORi sensor were placed. The patients were preoxygenated with a facemask (flow rate of 8 to 10 liters/minute) for 3 minutes with spontaneous ventilation. Propofol (2-2.5 mg/kg), fentanyl (2-3 mcg/kg) and rocuronium (0.6-0.9 mg/kg) were administrated to achieve anesthesia induction during following 3 minutes. The patient was keeping ventilated manually by the anesthesiologist during the induction phase and intubated under direct visualization with a video-assisted laryngoscope at 6 minutes. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. The patients remained apneic. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds. Arterial blood is sampled every minute, from preoxygenation to resumed ventilation, to observe blood oxygen concentration changes.
- Conditions
- Desaturation of Blood, Anesthesia
- Being tested
- Oxygen reserve index
- Keywords
- Oxygen reserve index, Induction of general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen reserve indexDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen reserve index | Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia and did not match the exclusion criteria. Receives: Device: Oxygen reserve index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional warning time provided by ORi trigger
The ORi peak warning time was defined as the duration from ORi decreased by 0.05 from the plateau or peak values until SpO2 decreased to 90%. The ORi 0.55 warning time was defined as the duration from the ORi value was 0.55 to SpO2 90%. The SpO2 waring time was defined as the duration from SpO2 98% to 90%. The added warning time provided by ORi peak or ORi 0.55 was defined as the difference between ORi peak warning time, ORi 0.55 warning time, and SpO2 warning time. The investigators will check the duration of the additional warning time provided by the ORi trigger.
Measured: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
Secondary outcomes (1)
Correlation between ORi and PaO2
The Oxygen Reserve Index is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status in the moderate hyperoxic range (PaO2 of about 100 to 200 mmHg). The investigators will check the correlation between ORi and PaO2 in our study.
Measured: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Mar 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Desaturation of BloodStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hung-Wei Cheng, MD, Principal investigator, Taipei Veteran General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976504
- Sponsor's protocol ID
- 2019-06-1-018CC
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep;123(3):626-33. doi: 10.1213/ANE.0000000000001262.
PubMed 27007078Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.
PubMed 28791567Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, Ezri T. Oxygen Reserve Index: A Novel Noninvasive Measure of Oxygen Reserve--A Pilot Study. Anesthesiology. 2016 Apr;124(4):779-84. doi: 10.1097/ALN.0000000000001009.
PubMed 26978143Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.
PubMed 32815872Cheng HW, Yeh CY, Chang MY, Ting CK, Chang PL. How early warning with the Oxygen Reserve Index (ORi) can improve the detection of desaturation during induction of general anesthesia? J Clin Monit Comput. 2022 Oct;36(5):1379-1385. doi: 10.1007/s10877-021-00776-z. Epub 2021 Dec 25.
PubMed 34953137
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Warning for Desaturation by Oxygen Reserve Index During Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT04976504
- Acronym / sponsor ID
- 2019-06-1-018CC
- Conditions
- Desaturation of Blood, Anesthesia
- Keywords
- Oxygen reserve index, Induction of general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Jul 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.
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.
Detailed description
This is an observational study of the routine clinical practice with no specific additional interventions required.
The investigators enrolled the American Society of Anesthesiologists (ASA) physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. Patients were positioned supine on the operating room table. Standard monitors and the ORi sensor were placed. The patients were preoxygenated with a facemask (flow rate of 8 to 10 liters/minute) for 3 minutes with spontaneous ventilation. Propofol (2-2.5 mg/kg), fentanyl (2-3 mcg/kg) and rocuronium (0.6-0.9 mg/kg) were administrated to achieve anesthesia induction during following 3 minutes. The patient was keeping ventilated manually by the anesthesiologist during the induction phase and intubated under direct visualization with a video-assisted laryngoscope at 6 minutes. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. The patients remained apneic. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds. Arterial blood is sampled every minute, from preoxygenation to resumed ventilation, to observe blood oxygen concentration changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen reserve index | – | Device: Oxygen reserve indexMale and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia and did not match the exclusion criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia and did not match the exclusion criteria.
Key inclusion criteria (1 listed)
- Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia.
Key exclusion criteria (7 listed)
- Age <18 years
- Inability to give primary consent
- Pregnancy
- History of chronic obstructive pulmonary disease (COPD)
- History of asthma
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 |
|---|---|---|
| Oxygen reserve indexThis 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. | Device | Oxygen reserve index |
Primary outcome
Additional warning time provided by ORi trigger
Time frame: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
The ORi peak warning time was defined as the duration from ORi decreased by 0.05 from the plateau or peak values until SpO2 decreased to 90%. The ORi 0.55 warning time was defined as the duration from the ORi value was 0.55 to SpO2 90%. The SpO2 waring time was defined as the duration from SpO2 98% to 90%. The added warning time provided by ORi peak or ORi 0.55 was defined as the difference between ORi peak warning time, ORi 0.55 warning time, and SpO2 warning time. The investigators will check the duration of the additional warning time provided by the ORi trigger.
1 secondary outcome
Correlation between ORi and PaO2
Time frame: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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 26 Jul 2021.
- Background: PubMed 27007078Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep;123(3):626-33. doi: 10.1213/ANE.0000000000001262.
- Background: PubMed 28791567Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.
- Background: PubMed 26978143Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, Ezri T. Oxygen Reserve Index: A Novel Noninvasive Measure of Oxygen Reserve--A Pilot Study. Anesthesiology. 2016 Apr;124(4):779-84. doi: 10.1097/ALN.0000000000001009.
- Background: PubMed 32815872Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.
- Derived from this study: PubMed 34953137Cheng HW, Yeh CY, Chang MY, Ting CK, Chang PL. How early warning with the Oxygen Reserve Index (ORi) can improve the detection of desaturation during induction of general anesthesia? J Clin Monit Comput. 2022 Oct;36(5):1379-1385. doi: 10.1007/s10877-021-00776-z. Epub 2021 Dec 25.
- Individual participant dataSharing planned: Undecided
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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.
Hung-Wei Cheng, MD principal investigator
Taipei Veteran General Hospital, Taiwan
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 Desaturation of Blood and Anesthesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 7 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 26 Jul 2021. 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 Taiwan. 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?
Additional warning time provided by ORi trigger (time frame: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes). 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 NCT04976504, which also lists 5 linked publications.
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 26 Jul 2021.