Time to Reach 90% Endtidal Oxygen During PreoxygenationNCT03807375
The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time
A study testing CPAP preoxygenation in people with Time to Reach 90% Endtidal Oxygen During Preoxygenation, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Time to Reach 90% Endtidal Oxygen During Preoxygenation
- What is being tested?
- CPAP preoxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Jun 2019
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 20 and 50 years
- American Society of Anesthesiologists I, II or III
- Patients with body mass index of 40 and over
Who cannot join
- cardiopulmonary disease
- patients with previous abdominal or thoracic surgery or cerebrovascular disease
- story of intracranial hypertension or epilepsy
- patients with a story of difficult tracheal intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training Research Hospital
Ankara
About this study
Official title: Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery
The aim of the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic.
Read the detailed description
Criteria for inclusion in the study:
Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years 50 patients
- Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during preoxygenation will be included.
- Group: Patients undergoing preoxygenation without CPAP will be included
In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal CO2 value in this order will be recorded.
Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation and after intubation.
- Being tested
- CPAP preoxygenation
- Keywords
- CPAP(Continuous Positive Airway Pressure), Standard preoxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP preoxygenationOther
During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Other | During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed. Receives: Other: CPAP preoxygenation |
| standard preoxygenation | No intervention | During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of desaturation during intubation
Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery
Measured: 5 minutes
prevention of side effects of hypoxia
hypoxia-induced arrhythmia hypotension tachycardia
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Mar 2018
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Time to Reach 90% Endtidal Oxygen During 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkay baran akkuş, Ankara Diskapi Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807375
- Sponsor's protocol ID
- preoxygenation
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.
PubMed 26044934Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
PubMed 28099321
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03807375
- Acronym / sponsor ID
- preoxygenation
- Keywords
- CPAP(Continuous Positive Airway Pressure), Standard preoxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 16 Jan 2019 (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 the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic.
Detailed description
Criteria for inclusion in the study:
Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years 50 patients
- Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during preoxygenation will be included.
- Group: Patients undergoing preoxygenation without CPAP will be included
In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal CO2 value in this order will be recorded.
Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation and after intubation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Other | Other: CPAP preoxygenationDuring preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed. |
| standard preoxygenation | No intervention | –During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
- cardiopulmonary disease
- patients with previous abdominal or thoracic surgery or cerebrovascular disease
- story of intracranial hypertension or epilepsy
- patients with a story of difficult tracheal intubation
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 |
|---|---|---|
| CPAP preoxygenationDuring preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. | Other | CPAP |
Primary outcome
Prevention of desaturation during intubation
Time frame: 5 minutes
Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery
prevention of side effects of hypoxia
Time frame: 10 minutes
hypoxia-induced arrhythmia hypotension tachycardia
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 5 Jul 2019.
- Background: PubMed 26044934Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.
- Results publication: PubMed 28099321Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
- Individual participant dataSharing planned: No
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 CPAP preoxygenation in people with Time to Reach 90% Endtidal Oxygen During Preoxygenation, run by Ankara Diskapi Training 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 4 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 5 Jul 2019. 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?
Prevention of desaturation during intubation (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 NCT03807375, which also lists 2 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 5 Jul 2019.