HyperoxiaNCT04698863

Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia

An observational study of Hyperoxia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hyperoxia
What is being tested?: Oxygen reserve index
Type of treatment: Medical device
How many people: 2 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Apr 2019to 30 Mar 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Aged between 18-65 years undergoing tympanomastoidectomy surgery

Who may be able to join

American Society of Anesthesiologists (ASA) risk class I-II,
Undergoing tympanomastoidectomy

Who cannot join

Morbid obesity
Opioid sensitivity Alcohol or drug addiction
Chronic obstructive pulmonary disease
Coronary artery disease,
Congestive heart failure
Pronounced anemia
Have a history of liver or kidney disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Zonguldak Bülent Ecevit University
Zonguldak

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment of Oxygenation With Oxygen Reserve Index for Different Fresh Gas Flows in General Anesthesia Administration

To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

Conditions: Hyperoxia
Being tested: Oxygen reserve index
Keywords: General anesthesia, Oxygen reserve index, Oxygenation, Hyperoxia
Medical subject headings: Hyperoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxygen reserve indexDevice
eveluating oxygen reserve in blood

Study groups in NCT04698863
Study group	Role	What they receive
high flow rate		After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 4 L/min for Group High flow rate. Receives: Device: Oxygen reserve index
low flow rate		After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 1 L/min for Group Low flow rate. Receives: Device: Oxygen reserve index

What is being measured

The primary outcome is the main question the study is designed to answer.

to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia.
to assess oxygenation with the oxygen reserve index (ORI) in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.
Measured: During the surgery procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Mar 2020

First posted7 Jan 2021
Study start1 Apr 2019
Primary completion30 Mar 2020
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperoxiaStudies 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: Other
Time perspective: Prospective
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04698863
Sponsor's protocol ID: 2018-221-07/11
Status last verified: Jan 2021
First submitted: 4 Jan 2021
Last updated: 12 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia

All Hyperoxia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Oxygenation With Oxygen Reserve Index for Different Fresh Gas Flows in General Anesthesia Administration
ClinicalTrials.gov ID: NCT04698863
Acronym / sponsor ID: 2018-221-07/11
Conditions: Hyperoxia
Keywords: General anesthesia, Oxygen reserve index, Oxygenation, Hyperoxia
Study type: Observational
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 30 Mar 2020 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 7 Jan 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.

To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
high flow rate	–	Device: Oxygen reserve indexAfter intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 4 L/min for Group High flow rate.
low flow rate	–	Device: Oxygen reserve indexAfter intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane. Then the flow rate was set to 1 L/min for Group Low flow rate.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Aged between 18-65 years undergoing tympanomastoidectomy surgery

Key inclusion criteria (2 listed)

American Society of Anesthesiologists (ASA) risk class I-II,
Undergoing tympanomastoidectomy

Key exclusion criteria (7 listed)

Morbid obesity
Opioid sensitivity Alcohol or drug addiction
Chronic obstructive pulmonary disease
Coronary artery disease,
Congestive heart failure

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 indexeveluating oxygen reserve in blood	Device	high flow rate, low flow rate

Primary outcome

to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia.
Time frame: During the surgery procedure
to assess oxygenation with the oxygen reserve index (ORI) in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.

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 12 Jan 2021.
Individual participant dataSharing planned: No

Related trials for Hyperoxia

Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Hyperoxia, run by Zonguldak Bulent Ecevit University 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 2 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 12 Jan 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 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?

to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia. (time frame: During the surgery procedure). 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 NCT04698863.

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 12 Jan 2021.