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

Obesity Clinical Trial

— Ovesion  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03106974
• Other study ID #: totaltrackeca01
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2017
• Last updated: April 13, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2017
• Source: AnestesiaR
• Contact: Eugenio D. Martinez Hurtado, M.D.
• Email: OvesionTT[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Desaturation
• Endotracheal Intubation
• Obesity
• Ventilation

Intervention

Device:
• orotracheal intubation Macintosh Laryngoscope
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
• orotracheal intubation Totaltrack VLM
orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AnestesiaR

Country where clinical trial is conducted

Spain, 

Outcome

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