Time to Intubation (TTI) of Obese Patients. A Comparison Macintosh Laryngoscope and Stortz Video Laryngoscope

Obese Clinical Trial

— TTI  

Official title:

Time to Intubation in Obese Patients. A Comparison Between Macintosh Laryngoscope and Stortz Video Laryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827085
• Other study ID #: EPN2012/015
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: October 6, 2016
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope.

Description:

Obese patients are prone to develop desaturation soon after initiation of anaesthesia compared to patients of normal body weight. It is therefore important to keep the time from when spontaneous breathing to when the airway is secured with a orotracheal tube as short as possible. We will therefore investigate if it is possible to shorten this time by using a Stortz videolaryngoscope.

Patients 18-60 years with ASA grade 1-3 and BMI < 35 that turn up for planned surgery that demands the use of orotracheal tubing and controlled ventilation will be randomly and consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction of sleep, combined with Rocuronium for muscle relaxation.

After the induction and relaxation the intubation will be facilitated using either of two laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster intubation with the use of videolaryngoscope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60

• Obesity defined as BMI > 35

• ASA 1-3

Exclusion Criteria:

-known or suspected difficult airway

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Obese

Intervention

Device:
• Conventional Macintosh laryngoscope

• Stortz videolaryngoscope

Locations

Country	Name	City	State
Sweden	Department of Anaethesia and Intensive Care, University Hospital Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubation seconds (s)		Up to 1 minute	No
Secondary	Presence and level of postoperational throat pain	If throat pain is present, we will use a visual analogue scale to evaluate the level of throat pain 1h, 24h, 72h and 96h after extubation.	1 hour to 96 hours postoperative	No
Secondary	Ease of intubation		Two minutes	No
Secondary	Incidence of trauma in each group		Two minutes	No
Secondary	Number of attempts of intubation		Two minutes	No