Pulmonary DiseaseCRISPENNCT02981264
Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA
A study testing Transcricoid Injection and Spray as you go in people with Pulmonary Disease, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Transcricoid Injection and Spray as you go
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to Jan 2019
- 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
- Indication for EBUS TBNA
- Age > 18 years
Who cannot join
- Refusal of consent
- Known documented hypersensitivity to lignocaine
- Procedure performed under general anaesthesia
- Pregnancy
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- Bronchoscopy done through endotracheal or tracheostomy tube
Show all 10Show fewer
- Midline neck mass or thyroid enlargement making the identification of
- cricothyroid membrane difficult'
- Patients with central airway obstruction
- Patients with active ongoing hemoptysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.
Read the detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to transcricoid injection or spray as you go lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the use of transcricoid injection in one group.
During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure.
Post procedure, patients will record the pain experienced while undergoing the procedure on the VAS scale.
- Conditions
- Pulmonary Disease
- Being tested
- Transcricoid Injection, Spray as you go
- Keywords
- Bronchoscopy, Lignocaine, Endobronchial Ultrasound
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcricoid InjectionDrug
Also called Lignocaine delivered through the cricothyroid membrane
Spray as you goDrug
Also called Lignocaine delivered through the bronchoscope working channel.
| Study group | Role | What they receive |
|---|---|---|
| Transcricoid | Active comparator | Lignocaine delivery using transcricoid injection Receives: Drug: Transcricoid Injection |
| Spray as You go | Active comparator | Lignocaine delivery using spray as you go method Receives: Drug: Spray as you go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cough count
Cough count till reaching carina
Measured: At study completion approximately 12 months
Operator rated overall procedure satisfaction
Operator rated satisfaction on VAS scale
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Time from scope insertion to crossing the vocal cords
Time in seconds
Measured: At study completion approximately 12 months
Overall procedure duration
Time in minutes
Measured: At study completion approximately 12 months
Total Lignocaine dose
Total dose of lignocaine in milligrams
Measured: At study completion approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completionJan 2019
- Study completionJan 2019
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 Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karan Madan, All India Institute of Medical Sciences
- Investigators
- Randeep Guleria, MD, DM, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981264
- Sponsor's protocol ID
- Transcricoid EBUS RCT
- Acronym
- CRISPEN
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2016
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data on demographics and outcomes shall be available on reasonable request
Publications
Mittal S, Gupta N, Iyer H, Biswal SK, Tiwari P, Hadda V, Mohan A, Guleria R, Madan K. The cricothyroid versus Spray-As-You-Go method for topical anesthesia during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): The CRISPEN randomized clinical trial. Lung India. 2021 May-Jun;38(3):223-228. doi: 10.4103/lungindia.lungindia_801_20.
PubMed 33942745
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02981264
- Acronym / sponsor ID
- CRISPEN / Transcricoid EBUS RCT
- Conditions
- Pulmonary Disease
- Keywords
- Bronchoscopy, Lignocaine, Endobronchial Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 5 Dec 2016 (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.
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.
Detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to transcricoid injection or spray as you go lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the use of transcricoid injection in one group.
During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure.
Post procedure, patients will record the pain experienced while undergoing the procedure on the VAS scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcricoid | Active comparator | Drug: Transcricoid InjectionLignocaine delivery using transcricoid injection |
| Spray as You go | Active comparator | Drug: Spray as you goLignocaine delivery using spray as you go method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for EBUS TBNA
- Age > 18 years
Key exclusion criteria (10 listed)
- Refusal of consent
- Known documented hypersensitivity to lignocaine
- Procedure performed under general anaesthesia
- Pregnancy
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
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 |
|---|---|---|
| Transcricoid InjectionAlso: Lignocaine delivered through the cricothyroid membrane | Drug | Transcricoid |
| Spray as you goAlso: Lignocaine delivered through the bronchoscope working channel. | Drug | Spray as You go |
Primary outcome
Overall cough count
Time frame: At study completion approximately 12 months
Cough count till reaching carina
Operator rated overall procedure satisfaction
Time frame: Through study completion, an average of 1 year
Operator rated satisfaction on VAS scale
3 secondary outcomes
Time from scope insertion to crossing the vocal cords
Time frame: At study completion approximately 12 months
Overall procedure duration
Time frame: At study completion approximately 12 months
Total Lignocaine dose
Time frame: At study completion approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 33942745Mittal S, Gupta N, Iyer H, Biswal SK, Tiwari P, Hadda V, Mohan A, Guleria R, Madan K. The cricothyroid versus Spray-As-You-Go method for topical anesthesia during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): The CRISPEN randomized clinical trial. Lung India. 2021 May-Jun;38(3):223-228. doi: 10.4103/lungindia.lungindia_801_20.
- Individual participant dataSharing planned: Yes. The data on demographics and outcomes shall be available on reasonable request
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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.
Randeep Guleria, MD, DM study chair
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcricoid Injection and Spray as you go in people with Pulmonary Disease, run by All India Institute of Medical Sciences at 1 site in India.
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 10 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: finished, as of the sponsor's last update on 30 Nov 2020. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall cough count (time frame: At study completion approximately 12 months). The study lists 2 primary outcomes in all. 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 NCT02981264, 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 30 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.