Airway Complication of AnesthesiaNCT03586323
Awake Fiber Optic Intubation (AFOI) and Laryngeal Nervous Block
A study testing superior laryngeal nerve block with lidocaine in people with Airway Complication of Anesthesia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- superior laryngeal nerve block with lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2018to 1 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged >18 years
- undergoing elective AFOI for upper airway obstruction
Who cannot join
- patients with respiratory tirage and cornage
- Arnè multifactorial scale < 11
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome
Roma, 00100
Francesco Alessandri, MD, 3880594460, francesco.alessandri@uniroma1.it
Edoardo Piervincenti, MD, 3472259741, edoardo.piervincenti@gmail.com
About this study
Official title: Awake Fiber Optic Intubation (AFOI) in Patients With Stenosis of the Upper Airway: Utility of the Laryngeal Nervous Block
Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Superior laryngeal nerve block (SLNB) could be an alternative technique useful to reduce risks and to improve patient comfort. Aim of this study is to assess the procedural comfort of the SLNB during AFOI, in a population of patients suffering from severe airways obstruction undergoing pharyngeal-laryngeal surgery. 40 patients will be randomized in two groups(20 for each group) and will be treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. In group A will be associated the SLNB; placebo will be administered in group B.
Read the detailed description
Patients will be randomized in two groups: group A: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue, intercricoid block and SLNB; group B: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. After the first measurement of vital parameters (T0), patients will received a continuous intravenous infusion of remifentanil at a rate ranged between 0.05 and 0.15 mcg/kg/min, reached by titration of a conscious sedation plane corresponding to the 0/-1 stage of the RASS scale. In all patients of both groups topical anesthesia of the oropharynx mucosa will be performed through 10 puffs of 10% lidocaine spray at the back of the tongue and at the base of the palatopharyngeal and palatoglossal arch. In Group A SLNB will be performed by administering 4 ml of 1.5% lidocaine below the thyroid membrane, which is palpated in addition to the intercricoid block by translaringeal puncture and 4 ml of lidocaine 1,5%. In group B intercricoid block will be performed by translaringeal puncture and 4 ml of 1.5% lidocaine. Group B will receive placebo instead of the regional block. After regional anesthesia, the patient will be placed on the operating table with the head in a neutral position. The vital parameters and the level of sedation reached (T1) will be registered. If SpO2 will be less than 96%, the patient will be pre-oxygenated with FiO2 100%. AFOI procedure will be performed using a 4 mm Olympus LF-2 bronchoscope and spiral tracheal tubes (internal diameter of between 5-6 mm) will be used. Discomfort during AFOI will be evaluated through the Fiber Optic Intubation Comfort Score. During AFOI procedure, unstructured airway maneuvers (neck's hyperextension, jaw subluxation, and pulling the tongue manually) will be evaluated. Hypoxemia, aspiration of secretions and time to perform intubation will be reported.
After intubation, a new evaluation of the vital parameters will be performed (T2) and patients will undergo to a total intravenous general anesthesia in accordance with the current international protocols. The primary endpoint will be to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score > 1. Secondary endpoint will be incidence of hypoxemia, time required to intubate, intraprocedural hemodynamic stability, airway obstruction score, need to aspirate secretions during AFOI, Tracheal Tube Tolerance Score.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- superior laryngeal nerve block with lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior laryngeal nerve block with lidocaineDrug
Also called L-SLNB
SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane
| Study group | Role | What they receive |
|---|---|---|
| L-SLNB | Experimental | performed a superior laryngeal nerve block with lidocaine Receives: Drug: superior laryngeal nerve block with lidocaine |
| S-SLNB | Placebo comparator | performed a superior laryngeal nerve block with saline Receives: Drug: superior laryngeal nerve block with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
discomfort
to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score > 1
Measured: up to 10 minutes
Secondary outcomes (3)
incidence of hypoxemia
number of desaturation events
Measured: up to 10 minutes
time required to intubate
minutes to intubation
Measured: up to 10 minutes
intraprocedural hemodynamic stability
reducing blood pressure > 30%
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start15 Apr 2018
- Primary completion24 Jul 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Alessandri, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586323
- Sponsor's protocol ID
- AFOISUA
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Fiber Optic Intubation (AFOI) in Patients With Stenosis of the Upper Airway: Utility of the Laryngeal Nervous Block
- ClinicalTrials.gov ID
- NCT03586323
- Acronym / sponsor ID
- AFOISUA
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 24 Jul 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 13 Jul 2018 (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.
Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Superior laryngeal nerve block (SLNB) could be an alternative technique useful to reduce risks and to improve patient comfort. Aim of this study is to assess the procedural comfort of the SLNB during AFOI, in a population of patients suffering from severe airways obstruction undergoing pharyngeal-laryngeal surgery. 40 patients will be randomized in two groups(20 for each group) and will be treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. In group A will be associated the SLNB; placebo will be administered in group B.
Detailed description
Patients will be randomized in two groups: group A: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue, intercricoid block and SLNB; group B: treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. After the first measurement of vital parameters (T0), patients will received a continuous intravenous infusion of remifentanil at a rate ranged between 0.05 and 0.15 mcg/kg/min, reached by titration of a conscious sedation plane corresponding to the 0/-1 stage of the RASS scale. In all patients of both groups topical anesthesia of the oropharynx mucosa will be performed through 10 puffs of 10% lidocaine spray at the back of the tongue and at the base of the palatopharyngeal and palatoglossal arch. In Group A SLNB will be performed by administering 4 ml of 1.5% lidocaine below the thyroid membrane, which is palpated in addition to the intercricoid block by translaringeal puncture and 4 ml of lidocaine 1,5%. In group B intercricoid block will be performed by translaringeal puncture and 4 ml of 1.5% lidocaine. Group B will receive placebo instead of the regional block. After regional anesthesia, the patient will be placed on the operating table with the head in a neutral position. The vital parameters and the level of sedation reached (T1) will be registered. If SpO2 will be less than 96%, the patient will be pre-oxygenated with FiO2 100%. AFOI procedure will be performed using a 4 mm Olympus LF-2 bronchoscope and spiral tracheal tubes (internal diameter of between 5-6 mm) will be used. Discomfort during AFOI will be evaluated through the Fiber Optic Intubation Comfort Score. During AFOI procedure, unstructured airway maneuvers (neck's hyperextension, jaw subluxation, and pulling the tongue manually) will be evaluated. Hypoxemia, aspiration of secretions and time to perform intubation will be reported.
After intubation, a new evaluation of the vital parameters will be performed (T2) and patients will undergo to a total intravenous general anesthesia in accordance with the current international protocols. The primary endpoint will be to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score > 1. Secondary endpoint will be incidence of hypoxemia, time required to intubate, intraprocedural hemodynamic stability, airway obstruction score, need to aspirate secretions during AFOI, Tracheal Tube Tolerance Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-SLNB | Experimental | Drug: superior laryngeal nerve block with lidocaineperformed a superior laryngeal nerve block with lidocaine |
| S-SLNB | Placebo comparator | Drug: superior laryngeal nerve block with lidocaineperformed a superior laryngeal nerve block with saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged >18 years
- undergoing elective AFOI for upper airway obstruction
Key exclusion criteria (2 listed)
- patients with respiratory tirage and cornage
- Arnè multifactorial scale < 11
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 |
|---|---|---|
| superior laryngeal nerve block with lidocaineAlso: L-SLNBSLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane | Drug | L-SLNB, S-SLNB |
Primary outcome
discomfort
Time frame: up to 10 minutes
to evaluate if SLNB is able to reduce the degree of discomfort of the AFOI procedure measured with the relative risk of Fiber Optic Intubation Comfort Score > 1
3 secondary outcomes
incidence of hypoxemia
Time frame: up to 10 minutes
time required to intubate
Time frame: up to 10 minutes
intraprocedural hemodynamic stability
Time frame: up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superior laryngeal nerve block with lidocaine in people with Airway Complication of Anesthesia, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 2 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 17 Jul 2018. 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 Italy. 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. Some participants in this study may receive a placebo. 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 Francesco Alessandri, MD (3880594460, francesco.alessandri@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discomfort (time frame: up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.