Endotracheal IntubationNCT02395445
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management
A study testing orotracheal intubation in people with Endotracheal Intubation, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.
Trial summary
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- orotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Nov 2016
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective general anesthesia requiring OTI.
- Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
- Age ≥18 years.
- ASA I-III.
- Sufficient intellectual capacity to understand the procedure and equipment used.
- Do not submit predictors of difficult airway (Mallampati class III or IV; thyromental distance <6 cm, sternomental distance <12.5 cm, interincisal distance<4.0 cm, bite test II or III, cervical mobility <90 ° or history of difficult intubation).
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- Do not undergo thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
- BMI <30kg / m2
- Not presenting risk factors for aspiration
- Not presenting respiratory disease, coronary or cerebral vascular.
- Do not have a sore throat preoperative
Who cannot join
- Failure to meet the above criteria
- Pregnancy
- Allergy to any drug included in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management: a Randomised, Controlled Clinical Trial
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy
- Conditions
- Endotracheal Intubation
- Being tested
- orotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orotracheal intubationDevice
| Study group | Role | What they receive |
|---|---|---|
| Totaltrack | Active comparator | Indirect laryngoscopy Receives: Device: orotracheal intubation |
| Macintosh Laryngoscope | Active comparator | Direct laryngoscopy Receives: Device: orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time of successful intubation with the Macintosh laryngoscope and TotalTrack.
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Secondary outcomes (9)
IDS Scale
Measured: TOTI (up to 1 hour)
POGO Score
Measured: TOTI (up to 1 hour)
number of maneuvers
Measured: TOTI (up to 1 hour)
Number of attempts of endotracheal intubation
Measured: TOTI (up to 1 hour)
Position taken by the anesthesiologist during orotracheal intubation
Measured: TOTI (up to 1 hour)
hemodynamic response
Heart Ratio, Arterial Pressure
Measured: OTI pre and postintubation (up to 10 minutes)
Complications
Measured: OTI and postintubation ( up to 24 hours)
endotracheal intubation success rate of each device
Measured: TOTI (up to 1 hour)
Degree of satisfaction
Visual Analogic Scale
Measured: time of postintubation (up to 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Ángel Gómez-Ríos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Ángel Gómez-Ríos, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395445
- Sponsor's protocol ID
- MGR-TT-2015-F1
- Status last verified
- Nov 2016
- First submitted
- 9 Mar 2015
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. doi: 10.1016/j.bpa.2005.07.004.
PubMed 16408534Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.
PubMed 10522589
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Routine Airway Management: a Randomised, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02395445
- Acronym / sponsor ID
- MGR-TT-2015-F1
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Manuel Ángel Gómez-RíosUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Mar 2015 (estimated)
- 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.
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totaltrack | Active comparator | Device: orotracheal intubationIndirect laryngoscopy |
| Macintosh Laryngoscope | Active comparator | Device: orotracheal intubationDirect laryngoscopy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients undergoing elective general anesthesia requiring OTI.
- Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
- Age ≥18 years.
- ASA I-III.
- Sufficient intellectual capacity to understand the procedure and equipment used.
Key exclusion criteria (3 listed)
- Failure to meet the above criteria
- Pregnancy
- Allergy to any drug included in the protocol.
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 |
|---|---|---|
| orotracheal intubation | Device | Macintosh Laryngoscope, Totaltrack |
Primary outcome
Total time of successful intubation with the Macintosh laryngoscope and TotalTrack.
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
9 secondary outcomes
IDS Scale
Time frame: TOTI (up to 1 hour)
POGO Score
Time frame: TOTI (up to 1 hour)
number of maneuvers
Time frame: TOTI (up to 1 hour)
Number of attempts of endotracheal intubation
Time frame: TOTI (up to 1 hour)
Position taken by the anesthesiologist during orotracheal intubation
Time frame: TOTI (up to 1 hour)
hemodynamic response
Time frame: OTI pre and postintubation (up to 10 minutes)
Complications
Time frame: OTI and postintubation ( up to 24 hours)
endotracheal intubation success rate of each device
Time frame: TOTI (up to 1 hour)
Degree of satisfaction
Time frame: time of postintubation (up to 10 minutes)
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 7 Nov 2016.
- Background: PubMed 16408534Pearce A. Evaluation of the airway and preparation for difficulty. Best Pract Res Clin Anaesthesiol. 2005 Dec;19(4):559-79. doi: 10.1016/j.bpa.2005.07.004.
- Background: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Background: PubMed 10522589Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.
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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 orotracheal intubation in people with Endotracheal Intubation, run by Manuel Ángel Gómez-Ríos at 1 site in Spain.
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 11 inclusion and 3 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 7 Nov 2016. 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 Spain. 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?
Total time of successful intubation with the Macintosh laryngoscope and TotalTrack. (time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)). 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 NCT02395445, which also lists 3 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 7 Nov 2016.