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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group DL | Active Comparator | The control group consists of intubating the trachea with an endotracheal tube alone (without stylet). |
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| Group DLS | Experimental | The Experimental group consists of intubating the trachea with an endotracheal tube + stylet. |
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| Group VL | Experimental | The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope |
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| Group VLS | Experimental | The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Tube Alone | Procedure | Intubating the trachea with an endotracheal tube alone ( without stylet). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Arterial Pressure: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betul Basaran, MD, DESA | Karaman Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Training and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
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Participant and the healthcare worker who will perform preoperative and postoperative visit will be blinded to randomized study group.
| Endotracheal Tube+ Stylet | Procedure | Intubating the trachea with an endotracheal tube + stylet. |
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| Endotracheal Tube + Video-laryngoscope | Procedure | Intubating the trachea with an endotracheal tube + Video- laryngoscope |
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| Endotracheal tube + stylet with Video-laryngoscope | Procedure | Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope |
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Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
| Before induction to 3 min after intubation |
| Saturation | Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute | Before induction to 3 min after intubation |
| Incidence of severe complications following intubation | Hypoxia, collapse, cardiac arrest, death. | During intubation to 3 min after intubation |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |