AnesthesiaNCT05462327
Low Fresh Gas Flow in Prone Position
A study testing Low Fresh Gas Flow in Prone Position and Normal Fresh Gas Flow in Prone Position in people with Anesthesia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Low Fresh Gas Flow in Prone Position and Normal Fresh Gas Flow in Prone Position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 31 Mar 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing surgery in the prone position
- having an American Society of Anesthesiologists (ASA) physical status I to III
- willingness to participate in the study
Who cannot join
- having a Glasgow coma scale (GSC) score ≤ 12
- previous history of cranial surgery
- advanced cardiovascular and/or pulmonary disease
- mental retardation
- neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Sisli, 34384
About this study
Official title: Low Fresh Gas Flow and Normal Gas Flow Anesthesia in Patients Undergoing Surgery in Prone Position: Impact on Hemodynamics and Regional Cerebral Oxygenation
Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow.
Read the detailed description
Patients were randomly allocated to either low fresh gas flow(LF, 0,5 L/min during maintenance) or normal flow (NF, 2 L/min)) general anesthesia. In both groups, participants were first administered with 100% oxygen at a 4 L/min flow rate. Propofol 2-2,5 mg/kg, rocuronium bromide 0,6 mg/kg, and fentanyl 1 mcg/kg IV were used for anesthesia induction.In the operating room, pulse rate, mean arterial pressure (MAP), peripheral hemoglobin oxygen saturation (spO2), and right and left side regional cerebral oxygen saturation (Masimo's O3 regional oximetry device) were measured before premedication and anesthesia induction, at 10 minutes after endotracheal intubation, at 10 minutes after prone positioning, at 1st, 2nd, 3rd, 4th and 5th hours of operation, before repositioning to supine, after the resumption of supine position and at 5 minutes after extubation. In conclusion, low flow anesthesia in patients undergoing surgery in the prone position did not cause a reduction in cerebral oxygenation compared to normal flow.
- Conditions
- Anesthesia
- Being tested
- Low Fresh Gas Flow in Prone Position, Normal Fresh Gas Flow in Prone Position
- Keywords
- Hemodynamics, Low Flow Anesthesia, Near Infrared Spectroscopy, Prone Positioning, Regional Cerebral Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fresh Gas Flow in Prone PositionProcedure or surgery
In the low fresh gas flow group, the flow rate was reduced to 0.5 L/min
Normal Fresh Gas Flow in Prone PositionProcedure or surgery
In the normal flow rate group, the gas flow rate was reduced to 2 L/min during the maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| Low Fresh Gas Flow in Prone Position | Experimental | Low fresh gas flow (0,5 L/min during maintenance) Receives: Procedure: Low Fresh Gas Flow in Prone Position |
| Normal Fresh Gas Flow in Prone Position | Active comparator | Normal flow (2 L/min) in general anesthesia. Receives: Procedure: Normal Fresh Gas Flow in Prone Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low and Normal Fresh Gas Flow Difference in Prone Position
Whether low flow anesthesia in the prone position is safe in terms of systemic hemodynamics and cerebral oxygenation compared to normal flow anesthesia
Measured: Systemic and cerebral oxygenation values were measured 10 minutes after induction to general anesthesia and followed up to 10 minutes were left to completion of the surgery for about 5 hours, which may vary according to the duration of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Akdaş Tekin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462327
- Sponsor's protocol ID
- 48670771-514.10/1477
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient's sex, ages and additional conditions
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Fresh Gas Flow and Normal Gas Flow Anesthesia in Patients Undergoing Surgery in Prone Position: Impact on Hemodynamics and Regional Cerebral Oxygenation
- ClinicalTrials.gov ID
- NCT05462327
- Acronym / sponsor ID
- 48670771-514.10/1477
- Conditions
- Anesthesia
- Keywords
- Hemodynamics, Low Flow Anesthesia, Near Infrared Spectroscopy, Prone Positioning, Regional Cerebral Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 18 Jul 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.
Low flow anesthesia in the prone position was safe in terms of systemic hemodynamics and did not reduce cerebral oxygenation compared to normal flow.
Detailed description
Patients were randomly allocated to either low fresh gas flow(LF, 0,5 L/min during maintenance) or normal flow (NF, 2 L/min)) general anesthesia. In both groups, participants were first administered with 100% oxygen at a 4 L/min flow rate. Propofol 2-2,5 mg/kg, rocuronium bromide 0,6 mg/kg, and fentanyl 1 mcg/kg IV were used for anesthesia induction.In the operating room, pulse rate, mean arterial pressure (MAP), peripheral hemoglobin oxygen saturation (spO2), and right and left side regional cerebral oxygen saturation (Masimo's O3 regional oximetry device) were measured before premedication and anesthesia induction, at 10 minutes after endotracheal intubation, at 10 minutes after prone positioning, at 1st, 2nd, 3rd, 4th and 5th hours of operation, before repositioning to supine, after the resumption of supine position and at 5 minutes after extubation. In conclusion, low flow anesthesia in patients undergoing surgery in the prone position did not cause a reduction in cerebral oxygenation compared to normal flow.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fresh Gas Flow in Prone Position | Experimental | Procedure: Low Fresh Gas Flow in Prone PositionLow fresh gas flow (0,5 L/min during maintenance) |
| Normal Fresh Gas Flow in Prone Position | Active comparator | Procedure: Normal Fresh Gas Flow in Prone PositionNormal flow (2 L/min) in general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing surgery in the prone position
- having an American Society of Anesthesiologists (ASA) physical status I to III
- willingness to participate in the study
Key exclusion criteria (5 listed)
- having a Glasgow coma scale (GSC) score ≤ 12
- previous history of cranial surgery
- advanced cardiovascular and/or pulmonary disease
- mental retardation
- neurological 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 |
|---|---|---|
| Low Fresh Gas Flow in Prone PositionIn the low fresh gas flow group, the flow rate was reduced to 0.5 L/min | Procedure or surgery | Low Fresh Gas Flow in Prone Position |
| Normal Fresh Gas Flow in Prone PositionIn the normal flow rate group, the gas flow rate was reduced to 2 L/min during the maintenance phase. | Procedure or surgery | Normal Fresh Gas Flow in Prone Position |
Primary outcome
Low and Normal Fresh Gas Flow Difference in Prone Position
Time frame: Systemic and cerebral oxygenation values were measured 10 minutes after induction to general anesthesia and followed up to 10 minutes were left to completion of the surgery for about 5 hours, which may vary according to the duration of the surgery.
Whether low flow anesthesia in the prone position is safe in terms of systemic hemodynamics and cerebral oxygenation compared to normal flow anesthesia
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 18 Jul 2022.
- Individual participant dataSharing planned: Undecided. Patient's sex, ages and additional conditions
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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.
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?
A study testing Low Fresh Gas Flow in Prone Position and Normal Fresh Gas Flow in Prone Position in people with Anesthesia, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 5 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 18 Jul 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?
Low and Normal Fresh Gas Flow Difference in Prone Position (time frame: Systemic and cerebral oxygenation values were measured 10 minutes after induction to general anesthesia and followed up to 10 minutes were left to completion of the surgery for about 5 hours, which may vary according to the duration of the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2022.