PreoxygenationTTIMvsMASKNCT07914296
Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask
A study testing Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM) and Preoxygenation via Face mask in people with Preoxygenation, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Determining the subjective experience of receiving pre-oxygenation with either a face-mask or with the tip of the tube in the mouth (TTIM = TubeTipIn Mouth) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM) and Preoxygenation via Face mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Anesthesiologists participating in an airway course at Rigshosptalet, Copenhagen
Who cannot join
- Un-willingness to participate Contraindication to brief hyperoxia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask - a Cross-over Randomised Study
Determining the subjective experience of receiving pre-oxygenation with either a face-mask or with the tip of the tube in the mouth (TTIM = TubeTipIn Mouth)
Read the detailed description
Background:
Before anesthesia and other procedures the patients are offered additional oxygen. The traditional method is to let the patient breathe oxygen-enriched air or pure oxygen via a face mask for a period of time.
Some patients feel that this procedure is uncomfortable, leads to loss of control or is even claustrophobic.
An alternative is to let the patient breathe a similar oxygeenriched air via a plastic tube that the patient holds in the hand and places in the mouth. This is called Tube Tip In the Mouth (TTIM)
In the study the investigators ask healthy subjects to breathe via a face mask and via a tube in random order.
After having tried this the subject expresses his feeling of comfort/discomfort, of loss of control and of possibe feeling of claustrophobia for each method
- Conditions
- Preoxygenation
- Being tested
- Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM), Preoxygenation via Face mask
- Keywords
- preoxygenation, Face mask, Patient dyscomfort, perioxygenation, Tube Tip In the Mouth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM)Procedure or surgery
Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM)
Preoxygenation via Face maskProcedure or surgery
Preoxygenation via Face mask
| Study group | Role | What they receive |
|---|---|---|
| Tube Tip In the Mouth first | Experimental | In this arm the subject receives oxygen via the tip of the tube in the mouth first - followed by via a face mask Receives: Procedure: Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM) |
| Preoxygenation via Face mask first | Active comparator | The subject has preoxygenation via Face mask first Receives: Procedure: Preoxygenation via Face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
The participants reports on a 10-point scale from 1 = "Not uncomfortable at all" to 10 = Unbearable uncomfortable"
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Secondary outcomes (8)
Feeling of loss of control
The participants reports on a 10-point scale from 1 = "No loss of control" to 10 = "Complete loss of control"
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Feeling of claustrophobia
The participants reports on a 10-point scale from 1 = "no claustrophobia at all to 10 "Unbearable claustrophobia"
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
End expiratory O2 obtained during the preoxygenation
The End expiratory O2 obtained during the preoxygenation as measured via the anaesthesia machine
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Preference of technique
The fraction of participants who prefer the TTIM (Tube Tip In Mouth) preoxygenation method over the face mask method
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Consider TTIM preferable for some patients
The fraction of participants who considers that the TTIM techniques is preferable for some patients
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Considers that TTIM should be the default technique for preoxygenation
The fraction of participants that considers that TTIM should be the default technique for preoxygenation (instead of face mask preoxygenation)
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Would consider implementing TTIM in own practice Yes/no
The fraction of participants who would consider implementing TTIM in his own practice when giving preoxygenation to others in the future
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Number of encounters that the participating anaesthesiologist in his career has had patients who disliked the mask and would probably have preferred Tube tip in mouth (TTIM) as preoxygenation?
Number of encounters that the participating anaesthesiologist in his career has had patients who disliked the mask and would probably have preferred Tube tip in mouth (TTIM) as preoxygenation?
Measured: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael S Kristensen, MD, Principal investigator, Rigshospitalet, Copenhagen University Hospital, Section 6011, Copenhagen, DK-2100, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914296
- Sponsor's protocol ID
- TTIM F-26072379
- Acronym
- TTIMvsMASK
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data of the results for the primary and seconday outcomes will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask - a Cross-over Randomised Study
- ClinicalTrials.gov ID
- NCT07914296
- Acronym / sponsor ID
- TTIMvsMASK / TTIM F-26072379
- Conditions
- Preoxygenation
- Keywords
- preoxygenation, Face mask, Patient dyscomfort, perioxygenation, Tube Tip In the Mouth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Nov 2026 (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.
Determining the subjective experience of receiving pre-oxygenation with either a face-mask or with the tip of the tube in the mouth (TTIM = TubeTipIn Mouth)
Detailed description
Background:
Before anesthesia and other procedures the patients are offered additional oxygen. The traditional method is to let the patient breathe oxygen-enriched air or pure oxygen via a face mask for a period of time.
Some patients feel that this procedure is uncomfortable, leads to loss of control or is even claustrophobic.
An alternative is to let the patient breathe a similar oxygeenriched air via a plastic tube that the patient holds in the hand and places in the mouth. This is called Tube Tip In the Mouth (TTIM)
In the study the investigators ask healthy subjects to breathe via a face mask and via a tube in random order.
After having tried this the subject expresses his feeling of comfort/discomfort, of loss of control and of possibe feeling of claustrophobia for each method
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tube Tip In the Mouth first | Experimental | Procedure: Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM)In this arm the subject receives oxygen via the tip of the tube in the mouth first - followed by via a face mask |
| Preoxygenation via Face mask first | Active comparator | Procedure: Preoxygenation via Face maskThe subject has preoxygenation via Face mask first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiologists participating in an airway course at Rigshosptalet, Copenhagen
Key exclusion criteria (1 listed)
- Un-willingness to participate Contraindication to brief hyperoxia
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 |
|---|---|---|
| Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM)Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM) | Procedure or surgery | Tube Tip In the Mouth first |
| Preoxygenation via Face maskPreoxygenation via Face mask | Procedure or surgery | Preoxygenation via Face mask first |
Primary outcome
Comfort
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
The participants reports on a 10-point scale from 1 = "Not uncomfortable at all" to 10 = Unbearable uncomfortable"
8 secondary outcomes
Feeling of loss of control
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Feeling of claustrophobia
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
End expiratory O2 obtained during the preoxygenation
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Preference of technique
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Consider TTIM preferable for some patients
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Considers that TTIM should be the default technique for preoxygenation
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Would consider implementing TTIM in own practice Yes/no
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Number of encounters that the participating anaesthesiologist in his career has had patients who disliked the mask and would probably have preferred Tube tip in mouth (TTIM) as preoxygenation?
Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The raw data of the results for the primary and seconday outcomes will be shared upon request
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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.
Michael S Kristensen, MD principal investigator
Rigshospitalet, Copenhagen University Hospital, Section 6011, Copenhagen, DK-2100, Denmark.
Questions about this trial
What is this clinical trial studying?
A study testing Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM) and Preoxygenation via Face mask in people with Preoxygenation, run by Copenhagen University Hospital, Rigshospitalet.
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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael S Kristensen, MD (004521711702, michael.seltz.kristensen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure). 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 3 Nov 2026.