Pain, Postoperative Clinical Trial
Official title:
A Comparison of the Videolaryngoscope and Macintosh Laryngoscope for NIM-EMG Endotracheal Tube Placement: Prospective, Double Blind, Randomized Study
NCT number | NCT05366582 |
Other study ID # | Ismail02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2022 |
Est. completion date | November 1, 2022 |
Verified date | March 2023 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laryngeal nerve monitoring is performed to prevent intraoperative nerve damage in thyroidectomy operations. NIM-EMG intubation tube is used while monitoring the recurrent laryngeal nerve. Care should be taken when placing this tube. Ensure that the electrodes on the tube are in contact with the vocal cords. Both the macintosh laryngoscope and the videolaryngoscope can be used when inserting the NIM-EMG tube. The aim of our study is to compare these two intubation methods.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 1, 2022 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - The American Society of Anesthesiologists (ASA) physical status classification system 1-2 - Age 18-65 - Undergoing Elective Thyroid and Parathyroidectomy surgery - undergoing Intraoperative Recurrent Laryngeal Nerve Monitoring Exclusion Criteria: - History of head and neck surgery - Body mass index less than 19 or greater than 30 - Muscle relaxant allergy - Lidocaine allergy - IDS score >5 - Uncontrolled hypertension, bronchial asthma, tracheal pathology - undergoing emergency surgery - Cases that cannot give informed consent |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of intubation attempts | The number of intubation attempts between both groups will be recorded. that patients are intubated will be confirmed by the presence of end tidal carbon dioxide. | during intubation after induction of anesthesia | |
Primary | Difficulty of Laryngoscopy | The Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy.
Helbo-Hensen et al. with Steyn modification includes five criteria; ease of laryngoscopy, degree of coughing, position of vocal cords, jaw relaxation, and limb movement and graded on a 4-point scale.Total score of 5 will considere to be excellent, 6-10 good, 11-15 poor, and 16-20 bad. Total scores will divide into clinically acceptable and not acceptable scores (total score = 10 acceptable, >10 unacceptable). |
during intubation after induction of anesthesia | |
Primary | Difficulty of Intubation | The intubation difficulty scale (IDS) of patients will be used to determine the difficulty of intubation during laryngoscopy, and the Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy.
Intubation Difficulty Scale (IDS) score, which is a function of seven parameters, resulting in a progressive, quantitative determination of intubation complexity. intubation difficulty may be defined as a measure of the degree of divergence from a predefined "ideal" intubation, i.e., one performed without effort, on the first attempt, practiced by one operator, using one technique, with full visualization of the laryngeal aperture and vocal cords abducted. Such an intubation is accorded an IDS value of 0. Each variation from this defined "ideal" intubation increases the degree of difficulty, the overall score being the sum of all variations from this definition. Impossible intubation is defined by infinity (IDS =[infinity]). |
during intubation after induction of anesthesia | |
Primary | NIM-EMG tube placement success | After placing the special tube and checking its level and contact, the grounding subdermal needle electrodes will be placed on the shoulder and all of the electrodes will be connected to the main unit. The impedance of the electrodes will be measured and the tube will be fixed after the device confirms that the impedance values are below 4 kiloohm (kO). | during intubation after induction of anesthesia | |
Primary | Intubation time | After anesthesia induction and muscle relaxant, the time will be started when patients who are manually ventilated for 2 minutes are ready for intubation. When successful intubation is proven, the time will be stopped and the duration recorded. | during intubation after induction of anesthesia | |
Secondary | sore throat | Sore throat of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient. | up to 24 hours postoperative period | |
Secondary | dysphagia | dysphagia of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient. | up to 24 hours postoperative period | |
Secondary | patient satisfaction | It will be evaluated by the patient between zero and ten points according to the patient satisfaction scale and the severity of sore throat and hoarseness. The patient satisfaction score is scored over a minimum of 0 points and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction. | up to 24 hours postoperative period |
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