Desaturation, Endotracheal Intubation, Obesity, Ventilation
Conditions
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.
Interventions
DEVICEorotracheal intubation Macintosh Laryngoscope
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
DEVICEorotracheal intubation Totaltrack VLM
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
Sponsors
AnestesiaR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| POGO Score | Time of Orotracheal intubation (TOTI) (up to 1 hour) | POGO Score |
| 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) |
| Number of attempts of endotracheal intubation | Time of Orotracheal intubation (TOTI) (up to 1 hour) | Number of attempts of endotracheal intubation |
| IDS Scale | Time of Orotracheal intubation (TOTI) (up to 1 hour) | IDS Scale |
| number of maneuvers | Time of Orotracheal intubation (TOTI) (up to 1 hour) | number of maneuvers |
| 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 |
| Total time of successful intubation | Time of Orotracheal intubation (TOTI) (up to 1 hour) | Total time of successful intubation |
Countries
Spain
Contacts
Primary ContactEugenio D. Martinez Hurtado, M.D.
Outcome results
None listed