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

Study Overview
=================
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.

Official Title
-----------------
A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope

Conditions
-----------------
Endotracheal Intubation, Obesity, Desaturation, Ventilation

Intervention / Treatment
-----------------
* Device: orotracheal intubation Macintosh Laryngoscope
* Device: orotracheal intubation Totaltrack VLM


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macintosh Laryngoscope<br>orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy | Device: orotracheal intubation Macintosh Laryngoscope<br>* orotracheal intubation (OTI) after induction of anesthesia and complete relaxation<br>* Other names: OTI;|
| Active Comparator: Totaltrack VLM<br>orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy | Device: orotracheal intubation Totaltrack VLM<br>* orotracheal intubation (OTI) after induction of anesthesia and complete relaxation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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