Comparison Between a Standard Tube and the Ultra-thin Tritube for Intubation of the Trachea and for Maintaining Access to the Trachea After Anaesthesia, in Patients With an Expected Difficult Direct Laryngoscopy (Tritube)

February 28, 2024 updated by: Michael Seltz Kristensen

Sammenligning Mellem Standard Tube og Den Ultra-tynde Tritube® Til Intubation, og Til Opretholdelse af Adgang Til Trachea Efter anæstesi, Hos Patienter Med Forventet Vanskelig Direkte Laryngoskopi

The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In patients scheduled for surgery and anaesthesia in the Head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. The intubation is performed with an angulated video laryngoscope.

Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. The latter continues into the post-operative recovery-ward.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat
  • planned for oral intubation with video-laryngoscopy
  • with risk factors for difficult direct laryngoscopy

Exclusion Criteria:

  • Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough)
  • Patients planned for awake intubation
  • Patients where mask-ventilation is judged to could become impossible
  • Patients where access to the cricothyroid membrane is judged to be difficult or impossible
  • Patients in ASA (american Society of Anaesthesiologists) physical classification status >3
  • Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration
  • Patients with stridor
  • Patients with hypoxemia (Saturation < 90 % in room air)
  • Operation duration planned to > 2.5 hours
  • Patients with the need for a nerve-stimulation-tube during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tritube
Device: Tritube
The ultra thin tribute is used used for the ventilation of the patients in this arm
Active Comparator: Standard endotracheal tube
Device: Standard enditracheal tube
A standard endotracheal tube is used used for the ventilation of the patients in this arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Excellent intubation conditions
Time Frame: 2 hours
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The rate of interruption by the tube of the view to the vocal cords at any time, to such a degree that it disturbs the intubation
Time Frame: 2 hours
2 hours
The Intubation Difficulty Score (IDS)
Time Frame: 2 hours
The intubation difficulty scale , range 0 to 7, 0 indicates easy intubation, 1 - 5 indicates slight difficulty, 5< indicates moderate to major difficulty
2 hours
Time to intubated
Time Frame: 2 hours
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea
2 hours
Time to the patient becomes ventilated via the tube
Time Frame: 2 hours
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea and CO2 waveform is observed
2 hours
Number of intubation attempts
Time Frame: 2 hours
one attempt is every-time the tube is advanced past the incisors
2 hours
The rate of succesful intubation with 60 seconds
Time Frame: 1 minute
1 minute
Number of remodellings of the stilette
Time Frame: 2 hours
2 hours
rate of use for "reverse loading" of the tube on the stylet
Time Frame: 2 hours
2 hours
the "percent of glottic opening" , (POGO), Before the tube is inserted
Time Frame: 2 hours
2 hours
the"percent of glottic opening" , POGO, with the tube in place
Time Frame: 2 hors
2 hors
Intubation conditions Strom scale
Time Frame: 2 hours
Direction of the tube-stylet combination excellent/good/poor, easy/fair/difficult. Advancement of the tube-stylet combination excellent/good/poor easy/fair/difficult
2 hours
The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation
Time Frame: 2 hours
2 hours
The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery
Time Frame: 20 minutes
20 minutes
the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)
Time Frame: 4 hours
4 hours
The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)
Time Frame: 4 hours
4 hours
The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit
Time Frame: 4 hours
4 hours
The ration of patients who still has the Tritube or the tube-exchange-catheter in place one hour after arrival in the Post anaesthesia care unit the post-operative recovery unit
Time Frame: 4 hours
4 hours
The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit
Time Frame: 4 hours
Visual analog scale from 1-10, 1= no nuisance, 10= unberable
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michael Seltz Kristensen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael S Kristensen, MD, Rigshospitalet, University Hospital of Copenhagen Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-18023689 Tritube

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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