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

Not Applicable

• Conditions: Endotracheal Intubation; Desaturation; Ventilation; Obesity
• Interventions: Device: orotracheal intubation Macintosh Laryngoscope; Device: orotracheal intubation Totaltrack VLM

• Registration Number: NCT03106974
• Lead Sponsor: AnestesiaR

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-26
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14
• Study Start: 2017-05-01
• Primary Completion: 2018-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh Laryngoscope	orotracheal intubation Macintosh Laryngoscope	orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy
Totaltrack VLM	orotracheal intubation Totaltrack VLM	orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
number of maneuvers	Time of Orotracheal intubation (TOTI) (up to 1 hour)	number of maneuvers
Total time of successful intubation	Time of Orotracheal intubation (TOTI) (up to 1 hour)	Total time of successful intubation
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

Trial Locations

Locations (1)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain