Anesthesia Intubation ComplicationNCT05659758
Is Effective Preoxygenation in Elderly Patients Related to Position?
A study testing Head up positioning during preoxygenation in people with Anesthesia Intubation Complication, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Head up positioning during preoxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 19 Jul 2023
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age above 65 years
- ASA 1-2
Who cannot join
- heart failure
- uncooperative
- patients refusing well fitting face mask before reaching EtO2 85%
- chronic lung disease
- anemia (hb<8gr/dl)
- BMI>40
- neurological sequela
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.
Read the detailed description
Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Head up positioning during preoxygenation
- Keywords
- preoxygenation, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head up positioning during preoxygenationProcedure or surgery
patients will be preoxygenated in head up position
| Study group | Role | What they receive |
|---|---|---|
| control | Other | patients will be preoxygenated in supine position Receives: Procedure: Head up positioning during preoxygenation |
| 20 degree | Experimental | patients will be preoxygenated in 20 degrees head up position Receives: Procedure: Head up positioning during preoxygenation |
| 30 degree | Experimental | patients will be preoxygenated in 30 degrees head up position Receives: Procedure: Head up positioning during preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time ETO2 85%
Time to reach ETO2 85 %
Measured: Time between placement of face mask and end tidal oxygen concentration reaches 85 %
Secondary outcomes (1)
Desaturation time
Time to reach the Spo2 of 92 % after intubation
Measured: Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Aug 2022
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namik ozcan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659758
- Sponsor's protocol ID
- E1-22-2775
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Effective Preoxygenation in Elderly Patients Related to Position?
- ClinicalTrials.gov ID
- NCT05659758
- Acronym / sponsor ID
- E1-22-2775
- Conditions
- Anesthesia Intubation Complication
- Keywords
- preoxygenation, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 21 Dec 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.
The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.
Detailed description
Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Other | Procedure: Head up positioning during preoxygenationpatients will be preoxygenated in supine position |
| 20 degree | Experimental | Procedure: Head up positioning during preoxygenationpatients will be preoxygenated in 20 degrees head up position |
| 30 degree | Experimental | Procedure: Head up positioning during preoxygenationpatients will be preoxygenated in 30 degrees head up position |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age above 65 years
- ASA 1-2
Key exclusion criteria (7 listed)
- heart failure
- uncooperative
- patients refusing well fitting face mask before reaching EtO2 85%
- chronic lung disease
- anemia (hb<8gr/dl)
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 |
|---|---|---|
| Head up positioning during preoxygenationpatients will be preoxygenated in head up position | Procedure or surgery | 20 degree, 30 degree, control |
Primary outcome
Time ETO2 85%
Time frame: Time between placement of face mask and end tidal oxygen concentration reaches 85 %
Time to reach ETO2 85 %
1 secondary outcome
Desaturation time
Time frame: Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter
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 20 Jul 2023.
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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 Head up positioning during preoxygenation in people with Anesthesia Intubation Complication, run by Ankara City Hospital Bilkent 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 20 Jul 2023. 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?
Time ETO2 85% (time frame: Time between placement of face mask and end tidal oxygen concentration reaches 85 %). 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 20 Jul 2023.