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

NCT03106974 — Not applicable, Unknown, 1440 participants, AnestesiaR

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A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope

Registry	NCT03106974, acronym Ovesion
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, other
Enrollment	1440 (Estimated)
Sponsor	AnestesiaR (Other)
Conditions	Endotracheal Intubation, Obesity, Desaturation, Ventilation
Interventions	orotracheal intubation Macintosh Laryngoscope, orotracheal intubation Totaltrack VLM (Device)
Dates	start 2017-05-01 (estimated), primary completion 2018-05-01 (estimated), completion 2019-05-01 (estimated), first posted 2017-04-11, last updated 2017-04-14
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Macintosh Laryngoscope	Active comparator	Device: orotracheal intubation Macintosh Laryngoscope	orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy
Totaltrack VLM	Active comparator	Device: orotracheal intubation Totaltrack VLM	orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy

orotracheal intubation Macintosh Laryngoscope (Device), also known as OTI: orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
orotracheal intubation Totaltrack VLM (Device): orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

+Outcome measures

Primary outcomes

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 outcomes

Total time of successful intubation [Time of Orotracheal intubation (TOTI) (up to 1 hour)]: Total time of successful intubation
number of maneuvers [Time of Orotracheal intubation (TOTI) (up to 1 hour)]: number of maneuvers
IDS Scale [Time of Orotracheal intubation (TOTI) (up to 1 hour)]: IDS Scale
POGO Score [Time of Orotracheal intubation (TOTI) (up to 1 hour)]: POGO Score
Number of attempts of endotracheal intubation [Time of Orotracheal intubation (TOTI) (up to 1 hour)]: Number of attempts of endotracheal intubation
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)
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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Hospital Universitario Infanta Leonor	Madrid, Madrid	Spain	Recruiting

+Investigators

Maria Luisa Mariscal Flores, M.D., Principal investigator, Hospital Universitario Getafe
Míriam Sánchez Merchante, M.D., Principal investigator, Hospital Universitario Fundación Alcorcón
Sergio D. Bergese, M.D., Principal investigator, Clinical Faculty - Wexner Medical Center at The Ohio State University