Ovesion: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- saturation of blood oxygen at the end of orotracheal intubation [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.
Secondary Outcome Measures
- Total time of successful intubation [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
Total time of successful intubation
- number of maneuvers [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
number of maneuvers
- IDS Scale [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
IDS Scale
- POGO Score [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
POGO Score
- Number of attempts of endotracheal intubation [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
Number of attempts of endotracheal intubation
- hemodynamic response [TOTI pre and postintubation (up to 10 minutes)]
hemodynamic response
- Degree of satisfaction of the researcher [time of postintubation (up to 10 minutes)]
Visual Analogic Scale (0-5)
- adverse effects encountered during intubation [Time of Orotracheal intubation (TOTI) (up to 1 hour)]
adverse effects encountered during intubation
- Complications [Time Frame: TOTI and postintubation (up to 24 hours)]
Complications after intubation
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI > 30.
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ASA 1-3
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Scheduled surgeries that require orotracheal intubation.
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General anesthesia with neuromuscular relaxation before intubation.
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Patients who sign informed consent.
Exclusion Criteria:
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ASA 4
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Difficult airway already known.
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Alterations of airway documented, with previous tracheostomy or involve anatomical alterations.
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General anesthesia that not require orotracheal intubation or neuromuscular relaxation.
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Symptomatic gastro-esophageal reflux.
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Lap-Band carrier.
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Allergy medications to use.
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Urgent surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Infanta Leonor | Madrid | Spain | 28031 |
Sponsors and Collaborators
- AnestesiaR
Investigators
- Principal Investigator: Maria Luisa Mariscal Flores, M.D., Hospital Universitario Getafe
- Principal Investigator: Míriam Sánchez Merchante, M.D., Hospital Universitario Fundación Alcorcón
- Principal Investigator: Sergio D. Bergese, M.D., Clinical Faculty - Wexner Medical Center at The Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- totaltrackeca01