Clinical trial NCT03106974: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients
Official title: A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Intubation
Obesity
Desaturation
Ventilation
Lead sponsor: AnestesiaR
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: saturation of blood oxygen at the end of orotracheal intubation
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
Secondary outcomes:
measure: Total time of successful intubation
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: number of maneuvers
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: IDS Scale
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: POGO Score
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: Number of attempts of endotracheal intubation
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: hemodynamic response
timeFrame: TOTI pre and postintubation (up to 10 minutes)
measure: Degree of satisfaction of the researcher
timeFrame: time of postintubation (up to 10 minutes)
measure: adverse effects encountered during intubation
timeFrame: Time of Orotracheal intubation (TOTI) (up to 1 hour)
measure: Complications
timeFrame: Time Frame: TOTI and postintubation (up to 24 hours)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
affiliation: Hospital Universitario Getafe
name: Maria Luisa Mariscal Flores, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Fundación Alcorcón
name: Míriam Sánchez Merchante, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Faculty - Wexner Medical Center at The Ohio State University
name: Sergio D. Bergese, M.D.
role: PRINCIPAL_INVESTIGATOR
References: