Endotracheal IntubationOvesionNCT03106974
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients
A study testing orotracheal intubation Macintosh Laryngoscope and orotracheal intubation Totaltrack VLM in people with Endotracheal Intubation and Obesity, run by AnestesiaR at 1 site in Spain.
Trial summary
Airway management in obese patients has to consider that mask ventilation (DMV) risk is increased and difficult tracheal intubation (DTI) risk may be increased too. In obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (FRC), atelectasis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation, Obesity, Desaturation
- What is being tested?
- orotracheal intubation Macintosh Laryngoscope and orotracheal intubation Totaltrack VLM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 1 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30.
- ASA 1-3
- Scheduled surgeries that require orotracheal intubation.
- General anesthesia with neuromuscular relaxation before intubation.
- Patients who sign informed consent.
Who cannot join
- ASA 4
- Difficult airway already known.
- Alterations of airway documented, with previous tracheostomy or involve anatomical alterations.
- General anesthesia that not require orotracheal intubation or neuromuscular relaxation.
- Symptomatic gastro-esophageal reflux.
- Lap-Band carrier.
- Allergy medications to use.
- Urgent surgery.
Trial locations and contacts
1 site in 1 country.
Eugenio D. Martinez Hurtado, M.D. contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28031
Eugenio D. Martinez Hurtado, M.D., OvesionTT@gmail.com
Eugenio D. Martinez Hurtado, M.D.
About this study
Official title: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope
Airway management in obese patients has to consider that mask ventilation (DMV) risk is increased and difficult tracheal intubation (DTI) risk may be increased too.
In obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction and after tracheal intubation, because oxygenation maintenance is the cornerstone of the airway management of the obese patient.
Read more
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However, sometimes this technique is ineffective and poorly tolerated by the obese patient.
The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult airway management.
However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy in obese patients.
- Conditions
- Endotracheal Intubation, Obesity, Desaturation, Ventilation
- Being tested
- orotracheal intubation Macintosh Laryngoscope, orotracheal intubation Totaltrack VLM
- Medical subject headings
- Obesity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orotracheal intubation Macintosh LaryngoscopeDevice
Also called OTI
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
orotracheal intubation Totaltrack VLMDevice
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
| Study group | Role | What they receive |
|---|---|---|
| Macintosh Laryngoscope | Active comparator | orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy Receives: Device: orotracheal intubation Macintosh Laryngoscope |
| Totaltrack VLM | Active comparator | orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy Receives: Device: orotracheal intubation Totaltrack VLM |
What is being measured
The primary outcome is the main question the study is designed to answer.
saturation of blood oxygen at the end of orotracheal intubation
We will compare the blood oxygen saturation at the end of orotracheal intubation with macintosh and totaltrack.
The end of successful tracheal intubation will be established to obtain a curve of Capnography.
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Secondary outcomes (9)
Total time of successful intubation
Total time of successful intubation
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
number of maneuvers
number of maneuvers
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
IDS Scale
IDS Scale
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
POGO Score
POGO Score
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Number of attempts of endotracheal intubation
Number of attempts of endotracheal intubation
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
hemodynamic response
hemodynamic response
Measured: TOTI pre and postintubation (up to 10 minutes)
Degree of satisfaction of the researcher
Visual Analogic Scale (0-5)
Measured: time of postintubation (up to 10 minutes)
adverse effects encountered during intubation
adverse effects encountered during intubation
Measured: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Complications
Complications after intubation
Measured: Time Frame: TOTI and postintubation (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnestesiaR
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenio Martinez Hurtado, AnestesiaR
- Investigators
- Maria Luisa Mariscal Flores, M.D., Principal investigator, Hospital Universitario GetafeMíriam Sánchez Merchante, M.D., Principal investigator, Hospital Universitario Fundación AlcorcónSergio D. Bergese, M.D., Principal investigator, Clinical Faculty - Wexner Medical Center at The Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106974
- Sponsor's protocol ID
- totaltrackeca01
- Acronym
- Ovesion
- Status last verified
- Apr 2017
- First submitted
- 26 Mar 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. 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
- ClinicalTrials.gov ID
- NCT03106974
- Acronym / sponsor ID
- Ovesion / totaltrackeca01
- Conditions
- Endotracheal Intubation, Obesity, Desaturation, Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- AnestesiaRUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 11 Apr 2017 (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.
Airway management in obese patients has to consider that mask ventilation (DMV) risk is increased and difficult tracheal intubation (DTI) risk may be increased too.
In obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction and after tracheal intubation, because oxygenation maintenance is the cornerstone of the airway management of the obese patient.
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However, sometimes this technique is ineffective and poorly tolerated by the obese patient.
The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult airway management.
However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy in obese patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh Laryngoscope | Active comparator | Device: orotracheal intubation Macintosh Laryngoscopeorotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy |
| Totaltrack VLM | Active comparator | Device: orotracheal intubation Totaltrack VLMorotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI > 30.
- ASA 1-3
- Scheduled surgeries that require orotracheal intubation.
- General anesthesia with neuromuscular relaxation before intubation.
- Patients who sign informed consent.
Key exclusion criteria (8 listed)
- ASA 4
- Difficult airway already known.
- Alterations of airway documented, with previous tracheostomy or involve anatomical alterations.
- General anesthesia that not require orotracheal intubation or neuromuscular relaxation.
- Symptomatic gastro-esophageal reflux.
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 Macintosh LaryngoscopeAlso: OTIorotracheal intubation (OTI) after induction of anesthesia and complete relaxation | Device | Macintosh Laryngoscope |
| orotracheal intubation Totaltrack VLMorotracheal intubation (OTI) after induction of anesthesia and complete relaxation | Device | Totaltrack VLM |
Primary outcome
saturation of blood oxygen at the end of orotracheal intubation
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
We will compare the blood oxygen saturation at the end of orotracheal intubation with macintosh and totaltrack. The end of successful tracheal intubation will be established to obtain a curve of Capnography.
9 secondary outcomes
Total time of successful intubation
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
number of maneuvers
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
IDS Scale
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
POGO Score
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Number of attempts of endotracheal intubation
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
hemodynamic response
Time frame: TOTI pre and postintubation (up to 10 minutes)
Degree of satisfaction of the researcher
Time frame: time of postintubation (up to 10 minutes)
adverse effects encountered during intubation
Time frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Complications
Time frame: Time Frame: TOTI and postintubation (up to 24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Eugenio D. Martinez Hurtado, M.D. contact
Maria Luisa Mariscal Flores, M.D. principal investigator
Hospital Universitario Getafe
Míriam Sánchez Merchante, M.D. principal investigator
Hospital Universitario Fundación Alcorcón
Sergio D. Bergese, M.D. principal investigator
Clinical Faculty - Wexner Medical Center at The Ohio State University
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 Macintosh Laryngoscope and orotracheal intubation Totaltrack VLM in people with Endotracheal Intubation and Obesity, run by AnestesiaR 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenio D. Martinez Hurtado, M.D. (OvesionTT@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
saturation of blood oxygen at the end of orotracheal intubation (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?
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 14 Apr 2017.