Intubation Clinical Trial
Official title:
Method Evaluation Study of Truview PCD Versus MacIntosh Laryngoscope
Verified date | June 2012 |
Source | Aalborg Universitetshospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
Aim:
The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture
Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis
for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.
The laryngoscopes are compared according to their ability to visualize the glottis area
measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.
A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible
decrease of the saturation will also be made.
Hypothesis:
The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes
the intubation les difficult.
CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the
hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview
PCD™ laryngoscope.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients older than 18 years of age who are to undergo a surgery at the ENT department, Aalborg Hospital. - Patients who understand and accept the trial information. - SARI score 2-5. Exclusion Criteria: - SARI score 0-1 and > 5. - A need for acute initiation. (By acute initiation the endotracheal tube will be placed in trachea during the first laryngoscopy without prior spraying with local anesthesia). - If unexpected difficulties during the initiating anesthesia arise, the trial will be interrupted, and the patient will be treated according to the department's guidelines for the situation |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Per Henrik Lambert | Ålborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg Universitetshospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cormack Lehane (CL) grade | At the first laryngoscopy the patient is sprayed between plica vocalis with Lidocaine 4%, then the patient is ventilated by a mask. During the next laryngoscopy the intubation is performed (the endotracheal tube is placed in trachea). The patients are randomized by lottery as to which laryngoscope to be used first. After anesthesia induction, preceded by 3 minutes of preoxygenering, the first laryngoscope is used when spraying the patient with Lidocaine. Subsequently the patient is ventilated for 2 minutes, and then the intubation is performed by using the other laryngoscope. |
The seconds during intubation where the anaesthesiologist view the vocal cords to determine the CL grade.. | No |
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