Airway Complication of AnesthesiaNCT04623645
Ultrasound Guided Superior Laryngeal Nerve Block Compared With Blind Block Technique
A study testing ultrasound technique in people with Airway Complication of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- ultrasound technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists ( ASA ) physical status I and II.
- Age between 40-60 years.
- Modified Mallampati class III-IV .
Who cannot join
- Local pathology of the neck.
- Bleeding diathesis.
- Allergy to local anesthetic agent.
- Intellectual impairment.
- Psychiatric disease.
- Body mass index ≥30 kg/m2.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alshaymaa Mortada Ali Eltohry
Alexandria, Please Select An Option, 21500
Alshaymaa Mortada A Eltohry, 01006485550, alshaymaaali62@gmail.com
About this study
Official title: Ultrasound Guided Bilateral Superior Laryngeal Nerve Block Compared With Blind Block Technique For Awake Fibre-optic Intubation In Suspected Difficult Intubation
The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique.
Read the detailed description
Airway anesthesia is pivotal for successful awake intubation provided either topically or by nerves blocks. Airway blocks are technically harder to perform with more complications possibilities. However, in experienced hands, they can be useful as they provide better intubating conditions.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- ultrasound technique
- Keywords
- Suspected Difficult Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound techniqueDevice
evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve
| Study group | Role | What they receive |
|---|---|---|
| ultrasound group | Experimental | patient using ultrasound technique.probe will be placed over submandibular area, the thyrohoid muscle and thyrohyoid membrane will be identified between greater horn fo hyoid bone and thyroid cartilage , 3 ml of lignocaine will be placed on space between thim and the procedure will repeated on contra lateral side. Receives: Device: ultrasound technique |
| anatomical blind group | Active comparator | patient using anatomical land mark technique, internal branch of superior laryngeal nerve will be blocked slightly anterior to greater horn of hyoid bone . by 3 ml lignocaine . the procdure will be repeated on contra lateral side . Receives: Device: ultrasound technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment the quality of airway anesthesia
The Quality of Airway anesthesia will be graded as: 0 = no coughing or gagging in response to intubation, 1 = mild coughing or gagging that will not hinder intubation, 2 = moderate coughing or gagging that will interfere minimally with intubation,3 = severe coughing or gagging that make intubation difficult and 4 = very severe coughing or gagging that will require additional local anesthetic or change in technique to achieve successful intubation.
Measured: Up to 2 years post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startFeb 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaymaa Mortada Ali Eltohry, Ain Shams University
- Investigators
- Azza Mohamed Shafik, professor, Study chair, Ain shams university, faculty of medicineAbeer Mohamed Abdel-Aziz, professor, Study director, Ain shams university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623645
- Sponsor's protocol ID
- FMASU MS 19/ 2020
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.
PubMed 20865885Ramkumar V. Preparation of the patient and the airway for awake intubation. Indian J Anaesth. 2011 Sep;55(5):442-7. doi: 10.4103/0019-5049.89863.
PubMed 22174458
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Bilateral Superior Laryngeal Nerve Block Compared With Blind Block Technique For Awake Fibre-optic Intubation In Suspected Difficult Intubation
- ClinicalTrials.gov ID
- NCT04623645
- Acronym / sponsor ID
- FMASU MS 19/ 2020
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Suspected Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique.
Detailed description
Airway anesthesia is pivotal for successful awake intubation provided either topically or by nerves blocks. Airway blocks are technically harder to perform with more complications possibilities. However, in experienced hands, they can be useful as they provide better intubating conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound group | Experimental | Device: ultrasound techniquepatient using ultrasound technique.probe will be placed over submandibular area, the thyrohoid muscle and thyrohyoid membrane will be identified between greater horn fo hyoid bone and thyroid cartilage , 3 ml of lignocaine will be placed on space between thim and the procedure will repeated on contra lateral side. |
| anatomical blind group | Active comparator | Device: ultrasound techniquepatient using anatomical land mark technique, internal branch of superior laryngeal nerve will be blocked slightly anterior to greater horn of hyoid bone . by 3 ml lignocaine . the procdure will be repeated on contra lateral side . |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists ( ASA ) physical status I and II.
- Age between 40-60 years.
- Modified Mallampati class III-IV .
Key exclusion criteria (6 listed)
- Local pathology of the neck.
- Bleeding diathesis.
- Allergy to local anesthetic agent.
- Intellectual impairment.
- Psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound techniqueevaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve | Device | anatomical blind group, ultrasound group |
Primary outcome
assessment the quality of airway anesthesia
Time frame: Up to 2 years post baseline
The Quality of Airway anesthesia will be graded as: 0 = no coughing or gagging in response to intubation, 1 = mild coughing or gagging that will not hinder intubation, 2 = moderate coughing or gagging that will interfere minimally with intubation,3 = severe coughing or gagging that make intubation difficult and 4 = very severe coughing or gagging that will require additional local anesthetic or change in technique to achieve successful intubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 20865885Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.
- Background: PubMed 22174458Ramkumar V. Preparation of the patient and the airway for awake intubation. Indian J Anaesth. 2011 Sep;55(5):442-7. doi: 10.4103/0019-5049.89863.
Related trials for Airway Complication of Anesthesia
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza Mohamed Shafik, professor study chair
Ain shams university, faculty of medicine
Abeer Mohamed Abdel-Aziz, professor study director
Ain shams university, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound technique in people with Airway Complication of Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alshaymaa Mortada Ali Eltohry, M.B.B.CH (+201006485550, alshaymaaali62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment the quality of airway anesthesia (time frame: Up to 2 years post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.