General AnestheticNCT05329233
Comparison of the Effects of High, Low and Minimal Flow Anesthesia Managements on ORI and Partial Oxygen Pressure
An observational study of General Anesthetic, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to show that continuous oxygen reserve index monitoring is a non-invasive monitoring method that can be used as a supporting parameter to PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flow is used in general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- General Anesthetic
- What is being tested?
- Masimo Radical-7 Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Sep 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA II and III patients aged between 18-75 years, who were scheduled to undergo elective open abdominal surgery lasting <60 minutes under general anesthesia
Who may be able to join
- ASA II and III patients,
- Aged between 18-75 years,
- who were scheduled to undergo elective open abdominal surgery lasting <60 minutes under general anesthesia
Who cannot join
- refusal of consent to study inclusion by the patient or his/her guardian,
- inability to use the sensor due to finger deformation or hypoperfusion,
- having a history of malignant hyperthermia,
- presence of clinically significant anemia, morbid obesity, alcohol or drug addiction, having a severe cardiac, renal or hepatic impairment,
- having a history of cerebrovascular disease,
- being a pregnant or presently lactating and having local anesthetic or opioid sensitivity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Research and Education Hospital
Samsun, 55090
About this study
Official title: Continuous ORI Monitoring is a Non-invasive Monitoring Method
The aim of our study is to show that continuous oxygen reserve index monitoring is a non-invasive monitoring method that can be used as a supporting parameter to PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flow is used in general anesthesia.
Read the detailed description
Ninety patients included in the study were classified into three groups. After the high flow period, FGF and inspired oxygen fraction (FiO2) was set to be 4 L/m and 40% in group H (high flow), 1 L/m and 50% in group L (low flow) and 0.5 L/m and 68% in group M (minimal flow), respectively.
Patients were transferred into the operating room, monitored and premedication with 0.03 mg/kg of midazolam was administered. Subsequently, the right radial artery was cannulated under local anesthesia and basal blood samples were taken. After preoxygenation (100% O2, 6 L/min, 3 min.), anesthesia induction was performed with intravenous administration of 40-60 mg lidocaine, 2 mg/kg propofol, 0.6 mg/kg rocuronium and 1.5 mcg/kg fentanyl. Patients were ventilated in volume-controlled mode (Dräger Perseus® A500 Anaesthesia Workstation, Dräger, Germany) that allows continuous monitorization of airway pressure, exhaled gas volume, FiO2, volatile anesthetic substance concentration, and CO2 concentration within the scope of the Common European Standard EN 740. Medical air was used as the carrier gas. End-tidal carbon dioxide (EtCO2) was continuously monitored after intubation, and tidal volume and ventilation rates were adjusted to maintain EtCO2 at 30-40 mmHg. In maintenance, general anesthesia was provided in all three groups by inhalation of remifentanil 0.05-0.2 mcg/kg/min and FGF 4 L/min 50% oxygen-medical air mixture with 6-8% desflurane. After intubation, 6% desflurane was administered with a fresh gas flow of 4 L/min for 10 minutes in all three groups, and the MAC value was adjusted to 1.
Thereafter, oxygen 1 L/min, and medical air 3 L/min (FGF 4 L/min, FiO2 40%) were administered to patients in group H for high-flow anesthesia; oxygen 0.37 L/min, medical air 0.63 L/min (FGF 1 L/min, FiO2 50%) to patients in group L for low-flow anesthesia; oxygen 0.3 L/min and medical air 0.2 L/min (FGF 0.5 L/min, FiO2 68%) to patients in group M under minimal flow anesthesia. After reaching adequate MAC values after 10 minutes of intubation, FiO2 was reduced to 40% in Group H, keeping the FGF unchanged; in Group L fresh gas flow was reduced to 1 L/min, in Group M fresh gas flow was reduced to 0.5 L/min, and the scale setting of desflurane was adjusted in order to achieve MAC 1 for the remainder of the surgery.
A disposable sensor (RD Rainbow Lite Set ORI Probe, Masimo Corp. Irvine CA), shielded from light, was placed on the left index finger to record the data displayed with Masimo Radical 7 pulse CO-Oximeter (Masimo Corp. Irvine CA).
At the end of the surgical procedure in all patients, the vaporizer was turned off and high FGF (4 L/min, FiO2 100%) was applied to ensure rapid removal of the anesthetic gases from the lungs, and manual ventilation was started. Sugammadex (2-4 mg/kg iv.) was administered to reverse the residual muscle relaxation at the end of the operation in patients who did not experience complications during the operation, and after spontaneous breathing was achieved, the patients were extubated in the operating room.
- Conditions
- General Anesthetic
- Being tested
- Masimo Radical-7 Pulse CO-Oximeter
- Keywords
- low flow anesthesia, oxygen reserve index, arterial oxygen pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7 Pulse CO-OximeterDevice
The Masimo Radical-7 Pulse CO-Oximeter is a device for the measurement of pulse oximetry, oxygen reserve index (ORi), perfusion index (PI), and pleth variability index (PVI). The device is the product of a company called Masimo Inc, Irvine, CA, USA
| Study group | Role | What they receive |
|---|---|---|
| minimal flow | For minimal-flow anesthesia, oxygen 0.3 L/min and medical air 0.2 L/min (FGF 0.5 L/min, FiO2 68%) were administered to patients in group M. Receives: Device: Masimo Radical-7 Pulse CO-Oximeter | |
| low flow | For low-flow anesthesia, oxygen 0.37 L/min and medical air 0.63 L/min (FGF 1 L/min, FiO2 50%) were administered to patients in group L. Receives: Device: Masimo Radical-7 Pulse CO-Oximeter | |
| high flow | For high-flow anesthesia, oxygen 1 L/min and medical air 3 L/min (FGF 4 L/min, FiO2 40%) were administered to patients in group H. Receives: Device: Masimo Radical-7 Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia
To show that continuous ORI monitoring is non-invasive monitoring that can be used as a supporting parameter for PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flows (4, 1, 0.5 L/min) are used in general anesthesia practice.
Measured: intraoperative period
Secondary outcomes (1)
The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia
Parameters were recorded at nine time frames: T1 (5 minutes before anesthesia induction), T2 (after intubation), T3 (at the start of 0.5-1-4 L/min), T4 (at the 10th minute of low flow), T5 (at the 30th minute of low flow), T6 (at the 60th minute of low flow), T7 (at the 90th minute of low flow), T8 (at the 120th minute of low flow), T9 (at the end of the surgery, ventilation with 100% oxygen) and T10 (5 min after extubation).
Measured: İntraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for General AnestheticStudies 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
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Kefeli Celik, Samsun Education and Research Hospital
- Investigators
- Zahide Doganay, Professor, Study chair, Samsun Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329233
- Sponsor's protocol ID
- KAEK-2020/1/1
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
Publications
Baxter AD. Low and minimal flow inhalational anaesthesia. Can J Anaesth. 1997 Jun;44(6):643-52; quiz 652-3. doi: 10.1007/BF03015449.
PubMed 9187785Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.
PubMed 30138170Scheeren 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 28791567
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous ORI Monitoring is a Non-invasive Monitoring Method
- ClinicalTrials.gov ID
- NCT05329233
- Acronym / sponsor ID
- KAEK-2020/1/1
- Conditions
- General Anesthetic
- Keywords
- low flow anesthesia, oxygen reserve index, arterial oxygen pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 14 Apr 2022 (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.
The aim of our study is to show that continuous oxygen reserve index monitoring is a non-invasive monitoring method that can be used as a supporting parameter to PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flow is used in general anesthesia.
Detailed description
Ninety patients included in the study were classified into three groups. After the high flow period, FGF and inspired oxygen fraction (FiO2) was set to be 4 L/m and 40% in group H (high flow), 1 L/m and 50% in group L (low flow) and 0.5 L/m and 68% in group M (minimal flow), respectively.
Patients were transferred into the operating room, monitored and premedication with 0.03 mg/kg of midazolam was administered. Subsequently, the right radial artery was cannulated under local anesthesia and basal blood samples were taken. After preoxygenation (100% O2, 6 L/min, 3 min.), anesthesia induction was performed with intravenous administration of 40-60 mg lidocaine, 2 mg/kg propofol, 0.6 mg/kg rocuronium and 1.5 mcg/kg fentanyl. Patients were ventilated in volume-controlled mode (Dräger Perseus® A500 Anaesthesia Workstation, Dräger, Germany) that allows continuous monitorization of airway pressure, exhaled gas volume, FiO2, volatile anesthetic substance concentration, and CO2 concentration within the scope of the Common European Standard EN 740. Medical air was used as the carrier gas. End-tidal carbon dioxide (EtCO2) was continuously monitored after intubation, and tidal volume and ventilation rates were adjusted to maintain EtCO2 at 30-40 mmHg. In maintenance, general anesthesia was provided in all three groups by inhalation of remifentanil 0.05-0.2 mcg/kg/min and FGF 4 L/min 50% oxygen-medical air mixture with 6-8% desflurane. After intubation, 6% desflurane was administered with a fresh gas flow of 4 L/min for 10 minutes in all three groups, and the MAC value was adjusted to 1.
Thereafter, oxygen 1 L/min, and medical air 3 L/min (FGF 4 L/min, FiO2 40%) were administered to patients in group H for high-flow anesthesia; oxygen 0.37 L/min, medical air 0.63 L/min (FGF 1 L/min, FiO2 50%) to patients in group L for low-flow anesthesia; oxygen 0.3 L/min and medical air 0.2 L/min (FGF 0.5 L/min, FiO2 68%) to patients in group M under minimal flow anesthesia. After reaching adequate MAC values after 10 minutes of intubation, FiO2 was reduced to 40% in Group H, keeping the FGF unchanged; in Group L fresh gas flow was reduced to 1 L/min, in Group M fresh gas flow was reduced to 0.5 L/min, and the scale setting of desflurane was adjusted in order to achieve MAC 1 for the remainder of the surgery.
A disposable sensor (RD Rainbow Lite Set ORI Probe, Masimo Corp. Irvine CA), shielded from light, was placed on the left index finger to record the data displayed with Masimo Radical 7 pulse CO-Oximeter (Masimo Corp. Irvine CA).
At the end of the surgical procedure in all patients, the vaporizer was turned off and high FGF (4 L/min, FiO2 100%) was applied to ensure rapid removal of the anesthetic gases from the lungs, and manual ventilation was started. Sugammadex (2-4 mg/kg iv.) was administered to reverse the residual muscle relaxation at the end of the operation in patients who did not experience complications during the operation, and after spontaneous breathing was achieved, the patients were extubated in the operating room.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| minimal flow | – | Device: Masimo Radical-7 Pulse CO-OximeterFor minimal-flow anesthesia, oxygen 0.3 L/min and medical air 0.2 L/min (FGF 0.5 L/min, FiO2 68%) were administered to patients in group M. |
| low flow | – | Device: Masimo Radical-7 Pulse CO-OximeterFor low-flow anesthesia, oxygen 0.37 L/min and medical air 0.63 L/min (FGF 1 L/min, FiO2 50%) were administered to patients in group L. |
| high flow | – | Device: Masimo Radical-7 Pulse CO-OximeterFor high-flow anesthesia, oxygen 1 L/min and medical air 3 L/min (FGF 4 L/min, FiO2 40%) were administered to patients in group H. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA II and III patients aged between 18-75 years, who were scheduled to undergo elective open abdominal surgery lasting <60 minutes under general anesthesia
Key inclusion criteria (3 listed)
- ASA II and III patients,
- Aged between 18-75 years,
- who were scheduled to undergo elective open abdominal surgery lasting <60 minutes under general anesthesia
Key exclusion criteria (6 listed)
- refusal of consent to study inclusion by the patient or his/her guardian,
- inability to use the sensor due to finger deformation or hypoperfusion,
- having a history of malignant hyperthermia,
- presence of clinically significant anemia, morbid obesity, alcohol or drug addiction, having a severe cardiac, renal or hepatic impairment,
- having a history of cerebrovascular disease,
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 |
|---|---|---|
| Masimo Radical-7 Pulse CO-OximeterThe Masimo Radical-7 Pulse CO-Oximeter is a device for the measurement of pulse oximetry, oxygen reserve index (ORi), perfusion index (PI), and pleth variability index (PVI). The device is the product of a company called Masimo Inc, Irvine, CA, USA | Device | high flow, low flow, minimal flow |
Primary outcome
The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia
Time frame: intraoperative period
To show that continuous ORI monitoring is non-invasive monitoring that can be used as a supporting parameter for PaO2 in blood gas in hypoxia and hyperoxia monitoring when different fresh gas flows (4, 1, 0.5 L/min) are used in general anesthesia practice.
1 secondary outcome
The use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia
Time frame: İntraoperative period
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 Apr 2022.
- Results publication: PubMed 9187785Baxter AD. Low and minimal flow inhalational anaesthesia. Can J Anaesth. 1997 Jun;44(6):643-52; quiz 652-3. doi: 10.1007/BF03015449.
- Results publication: PubMed 30138170Vos JJ, Willems CH, van Amsterdam K, van den Berg JP, Spanjersberg R, Struys MMRF, Scheeren TWL. Oxygen Reserve Index: Validation of a New Variable. Anesth Analg. 2019 Aug;129(2):409-415. doi: 10.1213/ANE.0000000000003706.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
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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.
Zahide Doganay, Professor study chair
Samsun Research and Education Hospital
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 General Anesthetic, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 Apr 2022. 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 Turkey (Türkiye). 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 use of continuous ORI monitoring as a supporting parameter to PaO2 in blood gasses during hypoxia and hyperoxia (time frame: intraoperative period). 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 NCT05329233, which also lists 3 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 22 Apr 2022.