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Not yet recruitingNCT07914296TTIMvsMASKUpdated Nov 3, 2026

Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask

An interventional study of 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 Preoxygenation, sponsored by Copenhagen University Hospital, Rigshospitalet. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Other

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Preoxygenation

Keywords

  • preoxygenation
  • Face mask
  • Patient dyscomfort
  • perioxygenation
  • Tube Tip In the Mouth
03

In context

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 39 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Anesthesiologists participating in an airway course at Rigshosptalet, Copenhagen

Exclusion criteria

Exclusion Criteria:

Un-willingness to participate Contraindication to brief hyperoxia

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Tube Tip In the Mouth first

    In this arm the subject receives oxygen via the tip of the tube in the mouth first - followed by via a face mask

    Procedure: Preoxygenation by Breathing via the tip of a tube hold in the mouth (= Tube Tip In the Mouth (TTIM)

  • Active comparator
    Preoxygenation via Face mask first

    The subject has preoxygenation via Face mask first

    Procedure: Preoxygenation via Face mask

Interventions

  • ProcedurePreoxygenation 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)

  • ProcedurePreoxygenation via Face mask

    Preoxygenation via Face mask

06

What researchers measure

Primary outcomes

  1. Comfort

    The participants reports on a 10-point scale from 1 = "Not uncomfortable at all" to 10 = Unbearable uncomfortable"

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

Secondary outcomes

  1. 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"

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  2. Feeling of claustrophobia

    The participants reports on a 10-point scale from 1 = "no claustrophobia at all to 10 "Unbearable claustrophobia"

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  3. End expiratory O2 obtained during the preoxygenation

    The End expiratory O2 obtained during the preoxygenation as measured via the anaesthesia machine

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  4. Preference of technique

    The fraction of participants who prefer the TTIM (Tube Tip In Mouth) preoxygenation method over the face mask method

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  5. Consider TTIM preferable for some patients

    The fraction of participants who considers that the TTIM techniques is preferable for some patients

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  6. 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)

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  7. 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

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

  8. 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?

    Time frame: From the start of the preoxygenation-procedure until the end of the preoxygenation-procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — The raw data of the results for the primary and seconday outcomes will be shared upon request

Supporting information: Clinical study report

Time frame: The data will be available after publication of the results in a PubMed-indexed journal

Access criteria: Upon request we will send all relevant information

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Nov 3, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914296
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Michael Seltz Kristensen (MD, Principal investigator, head of section for development and research, Section for Anaesthesia for head, neck, and maxillofacial surgery, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Nov 3, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 3, 2026

Study contacts

Michael S Kristensen, MD
Contact
michael.seltz.kristensen@gmail.com
004521711702
Michael S Kristensen, MD
principal investigator · Rigshospitalet, Copenhagen University Hospital, Section 6011, Copenhagen, DK-2100, Denmark.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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