Difficult AirwayPhase 2/3NCT01185535
Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation
A Phase 2/3 study testing times of topical anesthesia for glottis in people with Difficult Airway, run by Sun Yat-sen University at 1 site in China.
Trial summary
As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- times of topical anesthesia for glottis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class
Who cannot join
- Patients who have allergic reaction to the drugs used during anesthesia
- Patients who have a history of gastro-esophageal regurgitation, or with full stomach
- Patients with abnormality of cardiopulmonary function, renal and liver function
- Patients with abnormality of endocrine function
- Patients with increased intracranial pressure or epilepsy
Trial locations and contacts
1 site in 1 country.
China1 site
lab of The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition. In this study, the investigators will perform topical anesthesia with the nebulized 2% lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure stress factor during intubation period.Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during awake tracheal intubation.
Read the detailed description
90 adult patients for elective surgery under general anesthesia, aged 18-60 years old, Mallampti Ⅰ-Ⅱ class, , were randomly allocated to receive topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times(each group n=30). Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam (0.03mg/kg), propofol (2mg/kg/h) and remifentanil (0.05μg/kg/min). Ten minutes after sedation, topical anesthesia was performed with the nebulized 2% lidocaine at 10L/min oxygen flow rate, meantime patients were told to breathe deeply. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period. Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.
- Conditions
- Difficult Airway
- Being tested
- times of topical anesthesia for glottis
- Keywords
- topical anesthesia, tracheal intubation, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
times of topical anesthesia for glottisProcedure or surgery
Also called topical anesthesia
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
| Study group | Role | What they receive |
|---|---|---|
| 2 times topical anesthesia for glottis | Active comparator | Not described Receives: Procedure: times of topical anesthesia for glottis |
| 3 times topical anesthesia for glottis | Active comparator | Not described Receives: Procedure: times of topical anesthesia for glottis |
| 4 times topical anesthesia for glottis | Active comparator | Not described Receives: Procedure: times of topical anesthesia for glottis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation condition score during awake intubation period
Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)
Measured: one years
Secondary outcomes (3)
Stress factor during intubation period
Blood samples were drawn to measure the serum cortisol and insulin concentration.
Measured: one year
Life signs during intubation period
The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded.
Measured: one year
The complications during intubation period
The complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Jin s qing, doctor, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185535
- Sponsor's protocol ID
- 20081110362101197410300047
- Status last verified
- Apr 2010
- First submitted
- 26 Jul 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang H, Miao HS, Jin SQ, Chen LH, Tian JL. A pilot study of the effect of pressure-driven lidocaine spray on airway topical anesthesia for conscious sedation intubation. Chin Med J (Engl). 2011 Dec;124(23):3997-4001.
PubMed 22340331
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation
- ClinicalTrials.gov ID
- NCT01185535
- Acronym / sponsor ID
- 20081110362101197410300047
- Conditions
- Difficult Airway
- Keywords
- topical anesthesia, tracheal intubation, difficult airway
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Aug 2010 (estimated)
- 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.
As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition. In this study, the investigators will perform topical anesthesia with the nebulized 2% lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure stress factor during intubation period.Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during awake tracheal intubation.
Detailed description
90 adult patients for elective surgery under general anesthesia, aged 18-60 years old, Mallampti Ⅰ-Ⅱ class, , were randomly allocated to receive topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times(each group n=30). Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam (0.03mg/kg), propofol (2mg/kg/h) and remifentanil (0.05μg/kg/min). Ten minutes after sedation, topical anesthesia was performed with the nebulized 2% lidocaine at 10L/min oxygen flow rate, meantime patients were told to breathe deeply. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period. Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 times topical anesthesia for glottis | Active comparator | Procedure: times of topical anesthesia for glottis |
| 3 times topical anesthesia for glottis | Active comparator | Procedure: times of topical anesthesia for glottis |
| 4 times topical anesthesia for glottis | Active comparator | Procedure: times of topical anesthesia for glottis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class
Key exclusion criteria (5 listed)
- Patients who have allergic reaction to the drugs used during anesthesia
- Patients who have a history of gastro-esophageal regurgitation, or with full stomach
- Patients with abnormality of cardiopulmonary function, renal and liver function
- Patients with abnormality of endocrine function
- Patients with increased intracranial pressure or epilepsy
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 |
|---|---|---|
| times of topical anesthesia for glottisAlso: topical anesthesiatopical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times | Procedure or surgery | 2 times topical anesthesia for glottis, 3 times topical anesthesia for glottis, 4 times topical anesthesia for glottis |
Primary outcome
Intubation condition score during awake intubation period
Time frame: one years
Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)
3 secondary outcomes
Stress factor during intubation period
Time frame: one year
Life signs during intubation period
Time frame: one year
The complications during intubation period
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
- Derived from this study: PubMed 22340331Jiang H, Miao HS, Jin SQ, Chen LH, Tian JL. A pilot study of the effect of pressure-driven lidocaine spray on airway topical anesthesia for conscious sedation intubation. Chin Med J (Engl). 2011 Dec;124(23):3997-4001.
- PUMEDLink provided by the sponsor.
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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.
Jin s qing, doctor study director
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing times of topical anesthesia for glottis in people with Difficult Airway, run by Sun Yat-sen University at 1 site in China.
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 1 inclusion and 5 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 20 Aug 2010. 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 China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation condition score during awake intubation period (time frame: one years). 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 NCT01185535, which also lists 1 linked publication.
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 20 Aug 2010.