Clinical Trials Directory

Trials / Completed

CompletedNCT05026671

The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients

The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients: A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Karaman Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.

Detailed description

Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal \[or intergingival\] distances), and evaluation of status of dentition and neck movement will be noted. In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol. Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndotracheal Tube AloneIntubating the trachea with an endotracheal tube alone ( without stylet).
PROCEDUREEndotracheal Tube+ StyletIntubating the trachea with an endotracheal tube + stylet.
PROCEDUREEndotracheal Tube + Video-laryngoscopeIntubating the trachea with an endotracheal tube + Video- laryngoscope
PROCEDUREEndotracheal tube + stylet with Video-laryngoscopeIntubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Timeline

Start date
2021-09-01
Primary completion
2022-04-18
Completion
2022-04-30
First posted
2021-08-30
Last updated
2022-11-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05026671. Inclusion in this directory is not an endorsement.