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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03106974
Other study ID # totaltrackeca01
Secondary ID
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
Health authority
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 Totaltrackā„¢ (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.

Study Design


Related Conditions & MeSH terms


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)
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