Obesity Clinical Trial
— OvesionOfficial title:
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope
Verified date | April 2017 |
Source | AnestesiaR |
Contact | Eugenio D. Martinez Hurtado, M.D. |
OvesionTT[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Totaltrackā¢ (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.
Status | Recruiting |
Enrollment | 1440 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Infanta Leonor | Madrid |
Lead Sponsor | Collaborator |
---|---|
AnestesiaR |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | Total time of successful intubation | Total time of successful intubation | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | number of maneuvers | number of maneuvers | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | IDS Scale | IDS Scale | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | POGO Score | POGO Score | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | Number of attempts of endotracheal intubation | Number of attempts of endotracheal intubation | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | hemodynamic response | hemodynamic response | TOTI pre and postintubation (up to 10 minutes) | |
Secondary | Degree of satisfaction of the researcher | Visual Analogic Scale (0-5) | time of postintubation (up to 10 minutes) | |
Secondary | adverse effects encountered during intubation | adverse effects encountered during intubation | Time of Orotracheal intubation (TOTI) (up to 1 hour) | |
Secondary | Complications | Complications after intubation | Time Frame: TOTI and postintubation (up to 24 hours) |
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