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

NCT ID: NCT05026671

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-04-30

Brief 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

Intubation Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group DL

The control group consists of intubating the trachea with an endotracheal tube alone (without stylet).

Group Type: ACTIVE_COMPARATOR

Endotracheal Tube Alone

Intervention Type: PROCEDURE

Intubating the trachea with an endotracheal tube alone ( without stylet).

Group DLS

The Experimental group consists of intubating the trachea with an endotracheal tube + stylet.

Group Type: EXPERIMENTAL

Endotracheal Tube+ Stylet

Intervention Type: PROCEDURE

Intubating the trachea with an endotracheal tube + stylet.

Group VL

The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope

Group Type: EXPERIMENTAL

Endotracheal Tube + Video-laryngoscope

Intervention Type: PROCEDURE

Intubating the trachea with an endotracheal tube + Video- laryngoscope

Group VLS

The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Group Type: EXPERIMENTAL

Endotracheal tube + stylet with Video-laryngoscope

Intervention Type: PROCEDURE

Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Interventions

Endotracheal Tube Alone

Intubating the trachea with an endotracheal tube alone ( without stylet).

Intervention Type: PROCEDURE

Endotracheal Tube+ Stylet

Intubating the trachea with an endotracheal tube + stylet.

Intervention Type: PROCEDURE

Endotracheal Tube + Video-laryngoscope

Intubating the trachea with an endotracheal tube + Video- laryngoscope

Intervention Type: PROCEDURE

Endotracheal tube + stylet with Video-laryngoscope

Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with a documented body mass index (BMI) of ≥ 30.
• Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
• Willingness and ability to sign an informed consent document 18 - 80 years of age

Exclusion Criteria

• Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
• Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
• Emergency surgeries
• Pregnancy
• Any other conditions or use of any medication which may interfere with the conduct of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betul Basaran, MD, DESA

Role: STUDY_DIRECTOR

Karaman Training and Research Hospital

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

05-2021/04

Identifier Type: -

Identifier Source: org_study_id