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Completed

NCT Number: NCT05026671

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

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.

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Key information

Conditions

Intubation Time

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endotracheal Tube Alone

Procedure

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

Endotracheal Tube+ Stylet

Procedure

Intubating the trachea with an endotracheal tube + stylet.

Endotracheal Tube + Video-laryngoscope

Procedure

Intubating the trachea with an endotracheal tube + Video- laryngoscope

Endotracheal tube + stylet with Video-laryngoscope

Procedure

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

Primary outcomes

  1. Intubation Time Using a Stop Watch

    Time frame: Up to 3 minutes

    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.

Secondary outcomes

  1. Heart Rate

    Time frame: Before induction to 3 min after intubation

    Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute

  2. Mean Arterial Pressure:

    Time frame: Before induction to 3 min after intubation

    Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute

  3. Saturation

    Time frame: Before induction to 3 min after intubation

    Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute

  4. Incidence of severe complications following intubation

    Time frame: During intubation to 3 min after intubation

    Hypoxia, collapse, cardiac arrest, death.

  5. Glottis View Using the Cormack Lehane Score

    Time frame: Up to 1 minute

    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

  6. Glottis View Using the POGO Score

    Time frame: Up to 1 minute

    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.

  7. Number of intubation attempts

    Time frame: Up to postinduction 120 second

    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.

  8. Ease of Intubation

    Time frame: Up to 1 minute

    Subjective evaluation of the anesthesiologist, rated as (1) very easy, (2) easy, (3) moderate, (4) difficult, and (5) impossible.

  9. Complications related to intubation

    Time frame: postoperative 4th hour

    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.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2021
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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