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

AnestesiaR

Status: Unknown

Conditions: Ventilation; Obesity; Endotracheal Intubation; Desaturation

Treatments: Device: orotracheal intubation Macintosh Laryngoscope; Device: orotracheal intubation Totaltrack VLM

Study type: Interventional

Funder types: Other

Identifiers

NCT03106974

totaltrackeca01

Details and patient eligibility

About

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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,440 participants in 2 patient groups

Macintosh Laryngoscope

Active Comparator group

Description:

orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy

Treatment:

Device: orotracheal intubation Macintosh Laryngoscope

Totaltrack VLM

Active Comparator group

Description:

orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy

Treatment:

Device: orotracheal intubation Totaltrack VLM