Respiratory Disease Undergoing Elective Bronchoscopy.NCT02698007
Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
A study testing Laryngeal Mask Airway (LMA) in people with Respiratory Disease Undergoing Elective Bronchoscopy. and Chronic Obstructive Pulmonary Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years. Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease
- What is being tested?
- Laryngeal Mask Airway (LMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Oct 2016
- 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
- Above 18 y.o
- Competency to sign informed consent.
- Room air oxygen saturation above 95%
- Stable hemodynamically and respiratory during the start procedure.
- Undergoing elective bronchoscopy.
Who cannot join
- Pregnant women and special groups will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.
Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.
Read more
Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.
Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.
Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.
Or benefits and safety LMA in front of intubation during bronchoscopy.
Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .
Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.
Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.
Study group : LMA is inserted under sedation and used during the procedure.
Control group - performing bronchoscopy under sedation without LMA.
About 50 people are needed each group.
- Conditions
- Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease
- Being tested
- Laryngeal Mask Airway (LMA)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask Airway (LMA)Device
Fiberoptic bronchoscopy with the use of LMA
| Study group | Role | What they receive |
|---|---|---|
| without lma | No intervention | standard fiberoptic bronchoscopy without lma |
| with lma | Experimental | fiberoptic bronchoscopy with the use of lma Receives: Device: Laryngeal Mask Airway (LMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse oximetry <90%,
Measured: during bronchoscopy procedure
Percutaneous Carbon Dioxide >55%,
Measured: during bronchoscopy procedure
arrhythmia by ecg monitoring.
Measured: during bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Disease Undergoing Elective Bronchoscopy.Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698007
- Sponsor's protocol ID
- 0690-15-RMC
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
- ClinicalTrials.gov ID
- NCT02698007
- Acronym / sponsor ID
- 0690-15-RMC
- Conditions
- Respiratory Disease Undergoing Elective Bronchoscopy., Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Mar 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.
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.
Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.
Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.
Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.
Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.
Or benefits and safety LMA in front of intubation during bronchoscopy.
Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .
Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.
Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.
Study group : LMA is inserted under sedation and used during the procedure.
Control group - performing bronchoscopy under sedation without LMA.
About 50 people are needed each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without lma | No intervention | –standard fiberoptic bronchoscopy without lma |
| with lma | Experimental | Device: Laryngeal Mask Airway (LMA)fiberoptic bronchoscopy with the use of lma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above 18 y.o
- Competency to sign informed consent.
- Room air oxygen saturation above 95%
- Stable hemodynamically and respiratory during the start procedure.
- Undergoing elective bronchoscopy.
Key exclusion criteria (1 listed)
- Pregnant women and special groups will not be included in the study.
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 |
|---|---|---|
| Laryngeal Mask Airway (LMA)Fiberoptic bronchoscopy with the use of LMA | Device | with lma |
Primary outcome
pulse oximetry <90%,
Time frame: during bronchoscopy procedure
Percutaneous Carbon Dioxide >55%,
Time frame: during bronchoscopy procedure
arrhythmia by ecg monitoring.
Time frame: during bronchoscopy procedure
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 14 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway (LMA) in people with Respiratory Disease Undergoing Elective Bronchoscopy. and Chronic Obstructive Pulmonary Disease, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 1 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 14 Oct 2016. 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 Israel. 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?
pulse oximetry <90%, (time frame: during bronchoscopy procedure). The study lists 3 primary outcomes in all. 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 14 Oct 2016.