A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients (Ovesion)

April 13, 2017 updated by: Eugenio Martinez Hurtado, AnestesiaR

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.

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 Overview

Status

Status

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

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.

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 (Anticipated)

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.
1440

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

  • Spain
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Principal Investigator:
          • Eugenio D. Martinez Hurtado, M.D.
        • Principal Investigator:
          • Maria Luisa Mariscal Flores, M.D.
        • Principal Investigator:
          • Míriam Sánchez Merchante, M.D.
        • Principal Investigator:
          • Sergio D. Bergese, M.D.

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 30.
  • ASA 1-3
  • Scheduled surgeries that require orotracheal intubation.
  • General anesthesia with neuromuscular relaxation before intubation.
  • Patients who sign informed consent.

Exclusion Criteria:

  • 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.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

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.
ACTIVE_COMPARATOR: Macintosh Laryngoscope
orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy
Device: orotracheal intubation Macintosh Laryngoscope
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
Other Names:
  • OTI
ACTIVE_COMPARATOR: Totaltrack VLM
orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy
Device: orotracheal intubation Totaltrack VLM
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

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
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.
Time of Orotracheal intubation (TOTI) (up to 1 hour)

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
Total time of successful intubation
Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Total time of successful intubation
Time of Orotracheal intubation (TOTI) (up to 1 hour)
number of maneuvers
Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
number of maneuvers
Time of Orotracheal intubation (TOTI) (up to 1 hour)
IDS Scale
Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
IDS Scale
Time of Orotracheal intubation (TOTI) (up to 1 hour)
POGO Score
Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
POGO Score
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)
Number of attempts of endotracheal intubation
Time of Orotracheal intubation (TOTI) (up to 1 hour)
hemodynamic response
Time Frame: TOTI pre and postintubation (up to 10 minutes)
hemodynamic response
TOTI pre and postintubation (up to 10 minutes)
Degree of satisfaction of the researcher
Time Frame: time of postintubation (up to 10 minutes)
Visual Analogic Scale (0-5)
time of postintubation (up to 10 minutes)
adverse effects encountered during intubation
Time Frame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
adverse effects encountered during intubation
Time of Orotracheal intubation (TOTI) (up to 1 hour)
Complications
Time Frame: Time Frame: TOTI and postintubation (up to 24 hours)
Complications after intubation
Time Frame: TOTI and postintubation (up to 24 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.
AnestesiaR

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: Maria Luisa Mariscal Flores, M.D., Hospital Universitario Getafe
  • Principal Investigator: Míriam Sánchez Merchante, M.D., Hospital Universitario Fundacion Alcorcon
  • Principal Investigator: Sergio D. Bergese, M.D., Clinical Faculty - Wexner Medical Center at The Ohio State University

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 (ANTICIPATED)

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.
May 1, 2017

Primary Completion (ANTICIPATED)

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.
May 1, 2018

Study Completion (ANTICIPATED)

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.
May 1, 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).
March 26, 2017

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.
April 10, 2017

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.
April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
April 14, 2017

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.
April 13, 2017

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.
April 1, 2017

More Information

Terms related to this study

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.
  • totaltrackeca01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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