Comparison of Intubation With Nerve Block and With Sedation in Awake Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare intubation with nerve block with intubation with sedation in awake patients in terms of efficacy, ease, and the rate of complications and physician satisfaction

Official Title
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Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction

Conditions
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Intubation Complication

Intervention / Treatment
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* Drug: Nerve block with Lidocain
* Drug: Fentanyl
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for intubation with methods other than RSI Age>= 18 years Patient or patient's guardian's consent Exclusion Criteria: Need for RSI or crash intubation Allergy to Lidocain in block group Allergy to opioid drugs in sedation group Allergy to midazolam in either group

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intubation with sedation<br>Sedation with midazolam and analgesia with fentanyl | Drug: Fentanyl<br>* Fentanyl 2 microgram/Kg BW IV<br>Drug: Midazolam<br>* Midazolam 0.05 mg/kg BW IV infusion<br>|
| Experimental: Intubation with Nerve block<br>Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam | Drug: Nerve block with Lidocain<br>* Lidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg<br>Drug: Midazolam<br>* Midazolam 0.05 mg/kg BW IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for intubation in seconds | The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved. | From start of the intubation attempt for an average of one minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physicians' perception of the difficulty of the procedure | Physicians' perception about the difficulty of the procedure is assessed using a 5-point Likert type scale (ranging from very easy to very difficult)verbally administered to the healthcare provider immediately (within 30 minutes) after completion of the intubation | Within an average of 30 minutes after completion of the procedure | 
| Number of Participants with Adverse Events | Number of patients developing any of the following complications (cough, esophageal intubation) from the start of the procedure until 30 minutes after completion of the procedure. This will represent the rate of complications | From the start of the procedure until 30 minutes after the procedure is completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake intubation, Nerve block, Sedation, Physician satisfaction