View Clinical Trial (Medical Research Study)
Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
| City: |
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Louisville |
| State: |
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Kentucky |
| Zip Code: |
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40202 |
| Conditions: |
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Difficult Endotracheal Intubation |
| Purpose: |
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We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with
general anesthesia including endotracheal intubation. Patients qualify for the trial if they
are considered a difficult airway case as determined by measurement of common predictive
indices for difficult intubation (see inclusion criteria). All patients will be intubated
with a GVL. Patients will be randomly assigned to either having their ETT placed with use of
a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a
flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The
randomization will be stratified as to whether patients are categorized as predicted
difficult airway or have an immobilized cervical spine (C-collar in place).
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- BMI > 35
- Thyromental distance < 6 cm
- Sterno-mental distance < 12 cm
- Mallampati grade 3 and 4
- Interincisor distance < 38 mm
- Status of dentition: presence of buckteeth
- Neck movement < 35°
- Neck circumference >43 cm at the level of the thyroid cartilage
- Patients with immobilized cervical spine (C-collar in place).
- History of difficult laryngoscopy or intubation
Exclusion Criteria:
- Full stomach
- Hiatal hernia
- Severe GERD (Gastroesophageal reflux disease)
- Tumors of the upper airway
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| NCT ID: |
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NCT01215695 |
| Primary Contact: |
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Principal Investigator
Rainer Lenhardt, MD
University of Louisville
Rainer Lenhardt, MD
Phone: 502-852-3122
Email: rainer.lenhardt@louisville.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Louisville, Kentucky 40202
United States
Ozan Akca, m
Phone: 502-852-1739
Email: ozan.akca@louisville.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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