Intubation ComplicationPhase 3NCT01768377
Comparison of Intubation With Nerve Block and With Sedation in Awake Patients
A Phase 3 study testing Nerve block with Lidocain, Fentanyl and Midazolam in people with Intubation Complication, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Nerve block with Lidocain, Fentanyl and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Feb 2013
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for intubation with methods other than RSI
- Age>= 18 years
- Patient or patient's guardian's consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Imam Khomeini Hospital
Tehran, Tehran Province, 1417613151
Mohammad Jalili, MD, +98(21)66404377, mjalili@tums.ac.ir
Mohammad Jalili, MD
About this study
Official title: Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction
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
- Conditions
- Intubation Complication
- Keywords
- Awake intubation, Nerve block, Sedation, Physician satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve block with LidocainDrug
Lidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg
FentanylDrug
Fentanyl 2 microgram/Kg BW IV
MidazolamDrug
Midazolam 0.05 mg/kg BW IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Intubation with sedation | Active comparator | Sedation with midazolam and analgesia with fentanyl Receives: Drug: Fentanyl; Drug: Midazolam |
| Intubation with Nerve block | Experimental | Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam Receives: Drug: Nerve block with Lidocain; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of the intubation attempt for an average of one minutes
Secondary outcomes (2)
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
Measured: 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
Measured: From the start of the procedure until 30 minutes after the procedure is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Jalili, MD, Study director, TUMSAmir Nejati, MD, Principal investigator, TUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768377
- Sponsor's protocol ID
- 130-1928
- Status last verified
- Jan 2013
- First submitted
- 1 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction
- ClinicalTrials.gov ID
- NCT01768377
- Acronym / sponsor ID
- 130-1928
- Conditions
- Intubation Complication
- Keywords
- Awake intubation, Nerve block, Sedation, Physician satisfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 15 Jan 2013 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation with sedation | Active comparator | Drug: Fentanyl, Drug: MidazolamSedation with midazolam and analgesia with fentanyl |
| Intubation with Nerve block | Experimental | Drug: Nerve block with Lidocain, Drug: MidazolamLaryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidate for intubation with methods other than RSI
- Age>= 18 years
- Patient or patient's guardian's consent
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Nerve block with LidocainLidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg | Drug | Intubation with Nerve block |
| FentanylFentanyl 2 microgram/Kg BW IV | Drug | Intubation with sedation |
| MidazolamMidazolam 0.05 mg/kg BW IV infusion | Drug | Intubation with Nerve block, Intubation with sedation |
Primary outcome
Time required for intubation in seconds
Time frame: From start of the intubation attempt for an average of one minutes
The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.
2 secondary outcomes
physicians' perception of the difficulty of the procedure
Time frame: Within an average of 30 minutes after completion of the procedure
Number of Participants with Adverse Events
Time frame: From the start of the procedure until 30 minutes after the procedure is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation 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.
Mohammad Jalili, MD study director
TUMS
Amir Nejati, MD principal investigator
TUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerve block with Lidocain, Fentanyl and Midazolam in people with Intubation Complication, run by Tehran University of Medical Sciences at 1 site in Iran.
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 4 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 2013. 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 Iran. 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 phase mean?
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?
Contact Mohammad Jalili, MD (+98(912)5483998, mjalii@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for intubation in seconds (time frame: From start of the intubation attempt for an average of one 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 15 Jan 2013.