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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Endotracheal Intubation; Ventilation; Desaturation
• Intervention / Treatment: Device: orotracheal intubation Macintosh Laryngoscope; Device: orotracheal intubation Totaltrack VLM

• Study Type: Interventional
• Enrollment (Anticipated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugenio D. Martinez Hurtado, M.D.; Email: OvesionTT@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28031
    • Recruiting
    • Hospital Universitario Infanta Leonor
    • Contact: Eugenio D. Martinez Hurtado, M.D.; Email: OvesionTT@gmail.com
    • Principal Investigator: Eugenio D. Martinez Hurtado, M.D.
    • Principal Investigator: Maria Luisa Mariscal Flores, M.D.
    • Principal Investigator: Míriam Sánchez Merchante, M.D.
    • Principal Investigator: Sergio D. Bergese, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Macintosh Laryngoscope; orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy	Device: orotracheal intubation Macintosh Laryngoscope; orotracheal intubation (OTI) after induction of anesthesia and complete relaxation; Other Names: OTI
ACTIVE_COMPARATOR: Totaltrack VLM; orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy	Device: orotracheal intubation Totaltrack VLM; orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: AnestesiaR
• Investigators: Principal Investigator: Maria Luisa Mariscal Flores, M.D., Hospital Universitario Getafe; Principal Investigator: Míriam Sánchez Merchante, M.D., Hospital Universitario Fundacion Alcorcon; Principal Investigator: Sergio D. Bergese, M.D., Clinical Faculty - Wexner Medical Center at The Ohio State University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: totaltrackeca01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No