- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05550051
Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns.
Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns. A Randomized Controlled Study.
Study Overview
Status
Intervention / Treatment
Detailed Description
Adequate preparation for Awake Fiberoptic Intubation (AFOI) is an art of anesthesia which includes, many methods such as blocking nerves supplying the upper airway including the superior laryngeal, recurrent laryngeal, and glossopharyngeal nerves. Topical anesthesia via a special cannula as you proceed, and lignocaine nebulization. Succeeding in blocking the airway adequately is the first step towards a successful AFOI.
Although many studies have been done to compare the topical anesthesia technique versus the airway block techniques but theses studies have ignored the fact that in many cases of difficult airway indicated for AFOI there is limited or even absent neck mobility, and mouth opening both which are mandatory to perform an adequate airway neural block.
After anesthetizing the airway in both groups either by nebulization or airway block, an anesthesiologist who will be blinded to the study groups will perform the (AFOI) by using an endotracheal tube size 7.5 mm internal diameter endotracheal tube for males and 7 mm for female patients.
Vital signs such as HR, BP, and oxygen saturation (SpO2) will be recorded recorded immediately after intubation and 5 min postintubation and at every 10 minutes during surgery.
The patient response, and satisfaction with the technique will be recorded by using the revised non verbal pain scale (NVPS-R).
The (NVPS-R) is a multidimensional instrument formed of three behavioral (face, activity/movement, and guarding) responses, physiological indicators, and RR.
Patients will be randomly divided into two groups using a computer generated random number chart. Group (AB) will undergo AFOI after performing an airway block prior to the procedure while group (LN) will undergo AFOI after lignocaine nebulization 30 minutes prior to the procedure.
Group (AB) will have an upper airway block by using about lignocaine 2%; the following nerves will be blocked.
Bilateral superior laryngeal nerve block and will be performed after placing the patients in a supine position, with slight neck extension to identify the hyoid bone. Sterilization of the site of injection by 10% povidone iodine will be performed. After identification of the hyoid bone the bone will be move towards the site of injection, where a sterile 25G needle will be inserted laterally aiming at the greater cornu, and after hitting the bone with the needle, it will slide under the bone inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve.
Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by placing the patient supine, with the neck extended to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A 22G needle will be inserted perpendicular to the cricothyroid membrane to penetrate it while aspirating and once air bubbles appear this will mean that we are intra tracheal, then injection of 5ml of 4% lignocaine will result in coughing and dispersing of the LA, blocking the nerve.
While patients in group (LN) will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sameh Refaat, md
- Phone Number: +201001107173
- Email: avicen22@gmail.com
Study Contact Backup
- Name: Mohammed Murad, MD
- Phone Number: +201006512101
- Email: mohamed_mourad_80@live.com
Study Locations
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-
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Cairo, Egypt, 11728
- Sameh Refaat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients above 18 years with ASA classification II, III, and no known hypersensitivity for local anesthetics
Exclusion Criteria:
- Patient refusal
- Patients under 18 years
- Patients suffering from coagulopathies or bleeding tendencies
- Patients with ASA 4 classification
- Non cooperative patients
- Patients undergoing extensive facial reconstruction
- Patients with known hypersensitivity to lignocaine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: lignocaine nebulization before awake nasal fiberoptic intubation
Patients will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway.
After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.
|
Lignocaine nebulization for upper airway block during awake nasal fiberoptic intubation
|
Active Comparator: Upper airway block before awake nasal fiberoptic intubation
Upper airway block by using about lignocaine 2%, the block will be performed by:
|
Lignocaine nebulization for upper airway block during awake nasal fiberoptic intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient comfort during performing awake nasal fiberoptic intubation
Time Frame: 5 minutes
|
Will be measured by the revised non verbal pain sale
|
5 minutes
|
Time to performing awake nasal fiberoptic intubation
Time Frame: 5 minutes
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Will be measured by calculating the time to awake nasal fiberoptic intubation
|
5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R121/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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