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

Intubation Time Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026671
• Other study ID #: 05-2021/04
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2021
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Time

Intervention

Procedure:
• Endotracheal Tube Alone
Intubating the trachea with an endotracheal tube alone ( without stylet).
• Endotracheal Tube+ Stylet
Intubating the trachea with an endotracheal tube + stylet.
• Endotracheal Tube + Video-laryngoscope
Intubating the trachea with an endotracheal tube + Video- laryngoscope
• Endotracheal tube + stylet with Video-laryngoscope
Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Time Using a Stop Watch	The timing measurements will begin once the laryngoscope blade will be placed in the patient's mouth and ended when an end-tidal CO2 tracing will be detected.	Up to 3 minutes
Secondary	Heart Rate	Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute	Before induction to 3 min after intubation
Secondary	Mean Arterial Pressure:	Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute	Before induction to 3 min after intubation
Secondary	Saturation	Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute	Before induction to 3 min after intubation
Secondary	Incidence of severe complications following intubation	Hypoxia, collapse, cardiac arrest, death.	During intubation to 3 min after intubation
Secondary	Glottis View Using the Cormack Lehane Score	Cormack Lehane score classification; Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible	Up to 1 minute
Secondary	Glottis View Using the POGO Score	the POGO score evaluate the glottic view during tracheal intubation using a classification of 1/2/3/4 and a score of 0% to 100%, respectively. The POGO score denote visualization of the entire glottic opening from the anterior commissure to the posterior cartilages, and a score of 0% denotes inability to visualize any part of the glottic opening.	Up to 1 minute
Secondary	Number of intubation attempts	An intubation attempt will be defined as the insertion of the laryngoscope blade into the mouth of the patient, regardless of whether an attempt will be made to insert a tracheal tube. More than 5 attempts or 120 s will be regarded as a failure of intubation.	Up to postinduction 120 second
Secondary	Ease of Intubation	Subjective evaluation of the anesthesiologist, rated as (1) very easy, (2) easy, (3) moderate, (4) difficult, and (5) impossible.	Up to 1 minute
Secondary	Complications related to intubation	A postoperative follow-up assessment will be performed approximately 4 hr after surgery by a co-investigator blinded to the intubation device to evaluate the presence and severity of sore throat, any changes in voice, trauma to the lip, tongue, gum, or teeth.	postoperative 4th hour