The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group DL The control group consists of intubating the trachea with an endotracheal tube alone (without stylet). |
Procedure: Endotracheal Tube Alone
Intubating the trachea with an endotracheal tube alone ( without stylet).
|
| Experimental: Group DLS The Experimental group consists of intubating the trachea with an endotracheal tube + stylet. |
Procedure: Endotracheal Tube+ Stylet
Intubating the trachea with an endotracheal tube + stylet.
|
| Experimental: Group VL The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope |
Procedure: Endotracheal Tube + Video-laryngoscope
Intubating the trachea with an endotracheal tube + Video- laryngoscope
|
| Experimental: Group VLS The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope |
Procedure: Endotracheal tube + stylet with Video-laryngoscope
Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope
|
Outcome Measures
Primary Outcome Measures
- Intubation Time Using a Stop Watch [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 Outcome Measures
- Heart Rate [Before induction to 3 min after intubation]
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
- Mean Arterial Pressure: [Before induction to 3 min after intubation]
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
- Saturation [Before induction to 3 min after intubation]
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
- Incidence of severe complications following intubation [During intubation to 3 min after intubation]
Hypoxia, collapse, cardiac arrest, death.
- Glottis View Using the Cormack Lehane Score [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
- Glottis View Using the POGO Score [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.
- Number of intubation attempts [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.
- Ease of Intubation [Up to 1 minute]
Subjective evaluation of the anesthesiologist, rated as (1) very easy, (2) easy, (3) moderate, (4) difficult, and (5) impossible.
- Complications related to intubation [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with a documented body mass index (BMI) of ≥ 30.
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Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
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Willingness and ability to sign an informed consent document 18 - 80 years of age
Exclusion Criteria:
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Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
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Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
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Emergency surgeries
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Pregnancy
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Any other conditions or use of any medication which may interfere with the conduct of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karaman Training and Research Hospital | Karaman | Turkey | 70200 |
Sponsors and Collaborators
- Karaman Training and Research Hospital
Investigators
- Study Director: Betul Basaran, MD, DESA, Karaman Training and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-2021/04