PreoxygenationNCT06736197
An Algorithmic Approach to Preoxygenation
A study testing Group TVB, Group PSV and Group PSV+PEEP in people with Preoxygenation and Anaesthesia Induction, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoxygenation, Anaesthesia Induction, Non-invasive Positive Pressure Ventilation
- What is being tested?
- Group TVB, Group PSV and Group PSV+PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Jun 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgeries general anaesthesia was planned for a patient aged 18-65 years with ASA 1-2 physical condition.
Who cannot join
- Haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, BMI≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Algorithmic Approach to Preoxygenation: Stepwise Addition of Pressure Support and Positive End-expiratory Pressure When Tidal Volume Breathing is Inadequate. A Randomised Controlled Trial
The aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. The main question it aims to answer is:
- Will the proportion of patients receiving preoxygenation increase?
- Will the duration of preoxygenation decrease?
Participants will;
- 200 patients who were planned to undergo general anesthesia for elective surgeries
- aged between 18 and 65 years
- ASA 1-2 physical status
- ETO2 <90% at the end of the 3rd minute with spontaneous tidal volume breathing
Read the detailed description
The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
When adequate preoxygenation was achieved, the duration of preoxygenation, SpO2, end-tidal carbon dioxide (ETCO2), arterial blood pressures and heart rate values were recorded. Any adverse effects such as discomfort or gastric distension were noted.
- Being tested
- Group TVB, Group PSV, Group PSV+PEEP
- Keywords
- anaesthesia, preoxygenation, tidal volume, PSV, PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TVBProcedure or surgery
Also called Tidal volume breathing was continued.
Patients who could not reach ETO2 value 90 with tidal volume breathing for 3 min were included in Group TVB tidal volume breathing was continued for 2 min.
Group PSVProcedure or surgery
Preoxygenation was continued by providing 6cmH2O pressure support to the patients included in this group.
Group PSV+PEEPProcedure or surgery
At the 4th minute, preoxygenation was continued by adding 4 cmH2O positive end-expiratory pressure to the same 6 cmH2O pressure support for 1 min in patients whose end-tidal O2 value still reached 90% and who were included in this group.
| Study group | Role | What they receive |
|---|---|---|
| Group TVB | Experimental | Group TVB patients who could not reach 90% ETO2 at the end of the 3rd minute were continued with tidal volume breathing. Receives: Procedure: Group TVB |
| Group PSV | Experimental | Group PSV received 6 cm H2O positive pressure ventilation. Receives: Procedure: Group PSV |
| Group PSV+PEEP | Experimental | In addition to 6 cmH2O pressure support, 4 cmH2O end-expiratory positive pressure support was added to the patients included in Group PEEP. Receives: Procedure: Group PSV; Procedure: Group PSV+PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate preoxygenation.
The moment of ensuring adequate preoxygenation when the end-tidal oxygen value is 90 and above.
Measured: The moment when the end-tidal oxygen value of patients with insufficient preoxygenation at the end of the third minute with spontaneous tidal volume breathing is 90 and above.
Secondary outcomes (1)
Adverse effects
Any adverse effects such as discomfort or gastric distension were noted.
Measured: Within 5 min until target preoxygenation is reached.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreoxygenationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study was performed in 200 patients planned for general anaesthesia for elective surgery, aged 18-65 years, ASA 1-2 physical status, without premedication and ETO2 \<90% at the end of the 3rd minute with spontaneous TVB of 100% oxygen. The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagin Tanriverdi, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736197
- Sponsor's protocol ID
- PamukkaleUCTanriverdi-001
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: My first trial.
Publications
Tanriverdi C, Yuksel Tanriverdi S, Tomatir E. Preoxygenation algorithm: sequential PSV and PEEP versus tidal volume breathing. a randomized controlled trial. Perioper Med (Lond). 2025 Oct 15;14(1):111. doi: 10.1186/s13741-025-00575-z.
PubMed 41094613
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Algorithmic Approach to Preoxygenation: Stepwise Addition of Pressure Support and Positive End-expiratory Pressure When Tidal Volume Breathing is Inadequate. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06736197
- Acronym / sponsor ID
- PamukkaleUCTanriverdi-001
- Keywords
- anaesthesia, preoxygenation, tidal volume, PSV, PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 16 Dec 2024 (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 this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. The main question it aims to answer is:
- Will the proportion of patients receiving preoxygenation increase?
- Will the duration of preoxygenation decrease?
Participants will;
- 200 patients who were planned to undergo general anesthesia for elective surgeries
- aged between 18 and 65 years
- ASA 1-2 physical status
- ETO2 <90% at the end of the 3rd minute with spontaneous tidal volume breathing
Detailed description
The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
When adequate preoxygenation was achieved, the duration of preoxygenation, SpO2, end-tidal carbon dioxide (ETCO2), arterial blood pressures and heart rate values were recorded. Any adverse effects such as discomfort or gastric distension were noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study was performed in 200 patients planned for general anaesthesia for elective surgery, aged 18-65 years, ASA 1-2 physical status, without premedication and ETO2 <90% at the end of the 3rd minute with spontaneous TVB of 100% oxygen. The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
| Arm | Type | Receives |
|---|---|---|
| Group TVB | Experimental | Procedure: Group TVBGroup TVB patients who could not reach 90% ETO2 at the end of the 3rd minute were continued with tidal volume breathing. |
| Group PSV | Experimental | Procedure: Group PSVGroup PSV received 6 cm H2O positive pressure ventilation. |
| Group PSV+PEEP | Experimental | Procedure: Group PSV, Procedure: Group PSV+PEEPIn addition to 6 cmH2O pressure support, 4 cmH2O end-expiratory positive pressure support was added to the patients included in Group PEEP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgeries general anaesthesia was planned for a patient aged 18-65 years with ASA 1-2 physical condition.
Key exclusion criteria (1 listed)
- Haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, BMI≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.
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 |
|---|---|---|
| Group TVBAlso: Tidal volume breathing was continued.Patients who could not reach ETO2 value 90 with tidal volume breathing for 3 min were included in Group TVB tidal volume breathing was continued for 2 min. | Procedure or surgery | Group TVB |
| Group PSVPreoxygenation was continued by providing 6cmH2O pressure support to the patients included in this group. | Procedure or surgery | Group PSV, Group PSV+PEEP |
| Group PSV+PEEPAt the 4th minute, preoxygenation was continued by adding 4 cmH2O positive end-expiratory pressure to the same 6 cmH2O pressure support for 1 min in patients whose end-tidal O2 value still reached 90% and who were included in this group. | Procedure or surgery | Group PSV+PEEP |
Primary outcome
Adequate preoxygenation.
Time frame: The moment when the end-tidal oxygen value of patients with insufficient preoxygenation at the end of the third minute with spontaneous tidal volume breathing is 90 and above.
The moment of ensuring adequate preoxygenation when the end-tidal oxygen value is 90 and above.
1 secondary outcome
Adverse effects
Time frame: Within 5 min until target preoxygenation is reached.
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 16 Dec 2024.
- Derived from this study: PubMed 41094613Tanriverdi C, Yuksel Tanriverdi S, Tomatir E. Preoxygenation algorithm: sequential PSV and PEEP versus tidal volume breathing. a randomized controlled trial. Perioper Med (Lond). 2025 Oct 15;14(1):111. doi: 10.1186/s13741-025-00575-z.
- Individual participant dataSharing planned: Undecided. My first trial.
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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 Group TVB, Group PSV and Group PSV+PEEP in people with Preoxygenation and Anaesthesia Induction, run by Pamukkale 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 1 inclusion and 1 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 16 Dec 2024. 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?
Adequate preoxygenation. (time frame: The moment when the end-tidal oxygen value of patients with insufficient preoxygenation at the end of the third minute with spontaneous tidal volume breathing is 90 and above.). 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 NCT06736197, which also lists 1 linked publication.
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 16 Dec 2024.