ApneaNCT05396274
High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
A study testing High Flow Nasal Cannula in people with Apnea and Hypoxia, run by Turkish Society of Anesthesiology and Reanimation.
Trial summary
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- High Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2022to 30 Dec 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colonoscopy under elective conditions
- Patients aged 60 and over
- Having an American Society of Anesthesiology score of 1, 2, 3
- Approved and signed the informed consent form
Who cannot join
- Patients younger than 60 years
- Patients with an American Society of Anesthesiology score of 4 and above
- Emergency cases
- Patients who did not accept informed consent
- History of drug allergy and opioid tolerance
- Coagulation disorder
- Those who refused to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Read the detailed description
70 patients who underwent colonoscopy under elective conditions will be included in the study. Routine monitoring will be applied to the patients in the outpatient room in accordance with the standard protocol and the findings in the preoperative period will be recorded. The dose and frequency of anesthesia applied in the routine will not be interfered with and the recorded data will be collected by an observer other than the practitioner. Randomization between groups will be achieved by taking the patients on the surgical procedure list sequentially.
For both groups, after positioning the patients and placing the cannulas, preoxygenation will be performed for 5 minutes before induction of anesthesia. Oxygenation will be carried out at 35°C and 50 lt/min flow rate from the High Flow Nasal Cannula device, with inspired oxygen fraction equivalent to 40% in both groups, 5 lt/min in Group N, and inspired oxygen fraction equivalent to 40% in Group H, and immediately Anesthesia induction will then be applied.Oxygen saturation and other hemodynamic data of the patients in the room air before preoxygenation,oxygen saturation and hemodynamic data before induction after preoxygenation, oxygen saturation and hemodynamic data every minute during the procedure,oxygen saturation and hemodynamic data at the end of the procedure will be recorded. Interventions for respiratory safety, such as chin thrust, painful stimulus, inspired oxygen fraction increase, airway placement and mask ventilation, in case of apnea (stopping breathing for 10 seconds or more) or oxygen saturation ≤92% that may occur after induction until the end of the procedure , drug applications and other undesirable events will be recorded.
As a result of the study, High Flow Nasal Cannula and low flow nasal cannula, which is the standard conventional method, will be compared in terms of desaturation and hypoxemia in my colonoscopy procedures performed under sedation.
- Being tested
- High Flow Nasal Cannula
- Keywords
- High Flow Nasal Oxygen, nasal cannula, colonoscopy
- Medical subject headings
- Apnea, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
high flow nasale cannula
| Study group | Role | What they receive |
|---|---|---|
| standard nasal therapy | Active comparator | nasal oxygen was applied for procedure
%40 inspired oxygen fraction five minutes preoxygenation Receives: Device: High Flow Nasal Cannula |
| high flow nasal cannula | Active comparator | High Flow Nasal Oxygen was applied for procedure
%40 inspired oxygen fraction five minutes preoxygenation Receives: Device: High Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxia
oxygen saturation <92
Measured: during the procedure
apnea
spontaneous breathing not longer than 10 seconds
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start26 May 2022 (estimated)
- Primary completion12 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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 ApneaStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396274
- Sponsor's protocol ID
- gemlikanesthesia
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: researchers should explain the purpose of using individual participant data
Publications
Riccio CA, Sarmiento S, Minhajuddin A, Nasir D, Fox AA. High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial. J Clin Anesth. 2019 May;54:19-24. doi: 10.1016/j.jclinane.2018.10.026. Epub 2018 Nov 2.
PubMed 30391445Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.
PubMed 32925331
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT05396274
- Acronym / sponsor ID
- gemlikanesthesia
- Keywords
- High Flow Nasal Oxygen, nasal cannula, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 26 May 2022 (estimated)
- Primary completion
- 12 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 31 May 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.
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Detailed description
70 patients who underwent colonoscopy under elective conditions will be included in the study. Routine monitoring will be applied to the patients in the outpatient room in accordance with the standard protocol and the findings in the preoperative period will be recorded. The dose and frequency of anesthesia applied in the routine will not be interfered with and the recorded data will be collected by an observer other than the practitioner. Randomization between groups will be achieved by taking the patients on the surgical procedure list sequentially.
For both groups, after positioning the patients and placing the cannulas, preoxygenation will be performed for 5 minutes before induction of anesthesia. Oxygenation will be carried out at 35°C and 50 lt/min flow rate from the High Flow Nasal Cannula device, with inspired oxygen fraction equivalent to 40% in both groups, 5 lt/min in Group N, and inspired oxygen fraction equivalent to 40% in Group H, and immediately Anesthesia induction will then be applied.Oxygen saturation and other hemodynamic data of the patients in the room air before preoxygenation,oxygen saturation and hemodynamic data before induction after preoxygenation, oxygen saturation and hemodynamic data every minute during the procedure,oxygen saturation and hemodynamic data at the end of the procedure will be recorded. Interventions for respiratory safety, such as chin thrust, painful stimulus, inspired oxygen fraction increase, airway placement and mask ventilation, in case of apnea (stopping breathing for 10 seconds or more) or oxygen saturation ≤92% that may occur after induction until the end of the procedure , drug applications and other undesirable events will be recorded.
As a result of the study, High Flow Nasal Cannula and low flow nasal cannula, which is the standard conventional method, will be compared in terms of desaturation and hypoxemia in my colonoscopy procedures performed under sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard nasal therapy | Active comparator | Device: High Flow Nasal Cannulanasal oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation |
| high flow nasal cannula | Active comparator | Device: High Flow Nasal CannulaHigh Flow Nasal Oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Colonoscopy under elective conditions
- Patients aged 60 and over
- Having an American Society of Anesthesiology score of 1, 2, 3
- Approved and signed the informed consent form
Key exclusion criteria (7 listed)
- Patients younger than 60 years
- Patients with an American Society of Anesthesiology score of 4 and above
- Emergency cases
- Patients who did not accept informed consent
- History of drug allergy and opioid tolerance
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 |
|---|---|---|
| High Flow Nasal Cannulahigh flow nasale cannula | Device | high flow nasal cannula, standard nasal therapy |
Primary outcome
hypoxia
Time frame: during the procedure
oxygen saturation <92
apnea
Time frame: during the procedure
spontaneous breathing not longer than 10 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 30391445Riccio CA, Sarmiento S, Minhajuddin A, Nasir D, Fox AA. High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial. J Clin Anesth. 2019 May;54:19-24. doi: 10.1016/j.jclinane.2018.10.026. Epub 2018 Nov 2.
- Background: PubMed 32925331Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.
- Individual participant dataSharing planned: Yes. researchers should explain the purpose of using individual participant data
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula in people with Apnea and Hypoxia, run by Turkish Society of Anesthesiology and Reanimation.
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 4 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: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UTKU SAĞLAM, 1 (905079701310, utkusaglam23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoxia (time frame: during the procedure). 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 NCT05396274, 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 31 May 2022.