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

NCT03106974 | Unknown DMC FDA Device

• 1 other identifier: totaltrackeca01
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation; Obesity; Desaturation; Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Total time of successful intubation

  Time of Orotracheal intubation (TOTI) (up to 1 hour)

• number of maneuvers

  Time of Orotracheal intubation (TOTI) (up to 1 hour)

• IDS Scale

  Time of Orotracheal intubation (TOTI) (up to 1 hour)

• POGO Score

  Time of Orotracheal intubation (TOTI) (up to 1 hour)

• Number of attempts of endotracheal intubation

  Time of Orotracheal intubation (TOTI) (up to 1 hour)

Study Arms (2)

Macintosh Laryngoscope

ACTIVE COMPARATOR

orotracheal intubation (OTI) with Macintosh Laryngoscope Direct laryngoscopy

Device: orotracheal intubation Macintosh Laryngoscope

Totaltrack VLM

ACTIVE COMPARATOR

orotracheal intubation (OTI) with Totaltrack VlM Indirect laryngoscopy

Device: orotracheal intubation Totaltrack VLM

Interventions

orotracheal intubation Macintosh Laryngoscope DEVICE

orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

Also known as: OTI

Macintosh Laryngoscope

orotracheal intubation Totaltrack VLM DEVICE

orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

Totaltrack VLM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 30.
• ASA 1-3
• Scheduled surgeries that require orotracheal intubation.
• General anesthesia with neuromuscular relaxation before intubation.
• Patients who sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnestesiaR: lead

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28031, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Maria Luisa Mariscal Flores, M.D.

  Hospital Universitario Getafe

  PRINCIPAL INVESTIGATOR

• Míriam Sánchez Merchante, M.D.

  Hospital Universitario Fundación Alcorcón

  PRINCIPAL INVESTIGATOR

• Sergio D. Bergese, M.D.

  Clinical Faculty - Wexner Medical Center at The Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenio D. Martinez Hurtado, M.D.

CONTACT

OvesionTT@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 11, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

ES (1)