Lung DiseasesNCT05046223
Comparison of iGel and THRIVE on Bronchoscopic Interventions
A study testing The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc. and postoperative recovery in people with Lung Diseases and Total Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Total Intravenous Anesthesia, Tracheal Diseases
- What is being tested?
- The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc. and postoperative recovery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2021to 31 Jan 2023
- 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
- plan to receive bronchoscopic interventions with total intravenous anesthesia
Who cannot join
- awake bronchoscopy pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management
THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are rarely investigated.
Read the detailed description
THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. Unlike the nasal cannula with THRIVE, the tips of iGel are located in upper esophagi, it may affect the postoperative swallowing, especially for the aged group. However, the bronchoscopic approach may be easier for an established route to vocal cords. With shared airway for ventilation and interventions, CO2 elimination is hardly monitored besides the risk of desaturation.
In this study, THRIVE or iGel was planned to be randomized used for bronchoscopic interventions in an adult group (age 20-65) and an aged group (age over 65). The difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are compared between THRIVE and iGel groups.
- Being tested
- The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc., postoperative recovery
- Medical subject headings
- Lung Diseases, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.Procedure or surgery
Also called hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventions
cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
postoperative recoveryProcedure or surgery
anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1
| Study group | Role | What they receive |
|---|---|---|
| high-flow nasal oxygen | Experimental | THRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions Receives: Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.; Procedure: postoperative recovery |
| supraglottic devise | Active comparator | iGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions Receives: Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.; Procedure: postoperative recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
difficulty of bronchoscopic approach
time from insertion to visualize vocal cord, records of manipulations if applied
Measured: from bronchoscopic insertion to visualize vocal cords
response to spraying local anesthetics by bronchoscopy
the status of vocal cords visualized (relaxed, closed, relaxed but close with spray of local anesthetics); cough scale during bronchoscopic insertion and spray of local anesthetics
Measured: from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi
Secondary outcomes (5)
hemodynamic changes
changes on MAP (mmHg)
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
cough scale
cough intensity X times
Measured: from bronchoscopic insertion to the end of procedure
SPO2
pulse oximeter, hemoglobin saturation (%)
Measured: every 5 minutes from bronchoscopic insertion to the end of procedure
Transdermal CO2
data obyenied from transdermal CO2 (mmHg)
Measured: every 5 minutes from bronchoscopic insertion to the end of procedure
postanesthetic recovery
time stay in postoperative care unit (minutes)
Measured: from admission to PACU to discharge from PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Chang Tsai, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046223
- Sponsor's protocol ID
- 202011092RINA
- Status last verified
- Feb 2023
- First submitted
- 13 Aug 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if there is similar investigation
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management
- ClinicalTrials.gov ID
- NCT05046223
- Acronym / sponsor ID
- 202011092RINA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 16 Sep 2021 (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.
THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are rarely investigated.
Detailed description
THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. Unlike the nasal cannula with THRIVE, the tips of iGel are located in upper esophagi, it may affect the postoperative swallowing, especially for the aged group. However, the bronchoscopic approach may be easier for an established route to vocal cords. With shared airway for ventilation and interventions, CO2 elimination is hardly monitored besides the risk of desaturation.
In this study, THRIVE or iGel was planned to be randomized used for bronchoscopic interventions in an adult group (age 20-65) and an aged group (age over 65). The difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are compared between THRIVE and iGel groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-flow nasal oxygen | Experimental | Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc., Procedure: postoperative recoveryTHRIVE( Transnasal humidified rapid-insufflation ventilatory exchange), a method of high-flow nasal oxygen (HFNO), is planned to applied for bronchoscopic interventions |
| supraglottic devise | Active comparator | Procedure: The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc., Procedure: postoperative recoveryiGel, a supraglottic devise with tip in upper esophagus, is planned to applied for bronchoscopic interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- plan to receive bronchoscopic interventions with total intravenous anesthesia
Key exclusion criteria (1 listed)
- awake bronchoscopy pregnancy
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 |
|---|---|---|
| The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.Also: hemodynamic and ventilatory responses from insertion of broncoscopy to the end of bronchoscopic interventionscough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions | Procedure or surgery | high-flow nasal oxygen, supraglottic devise |
| postoperative recoveryanesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1 | Procedure or surgery | high-flow nasal oxygen, supraglottic devise |
Primary outcome
difficulty of bronchoscopic approach
Time frame: from bronchoscopic insertion to visualize vocal cords
time from insertion to visualize vocal cord, records of manipulations if applied
response to spraying local anesthetics by bronchoscopy
Time frame: from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi
the status of vocal cords visualized (relaxed, closed, relaxed but close with spray of local anesthetics); cough scale during bronchoscopic insertion and spray of local anesthetics
5 secondary outcomes
hemodynamic changes
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
cough scale
Time frame: from bronchoscopic insertion to the end of procedure
SPO2
Time frame: every 5 minutes from bronchoscopic insertion to the end of procedure
Transdermal CO2
Time frame: every 5 minutes from bronchoscopic insertion to the end of procedure
postanesthetic recovery
Time frame: from admission to PACU to discharge from PACU
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 16 Feb 2023.
- Individual participant dataSharing planned: Yes. if there is similar investigation
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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.
Fu-Chang Tsai study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc. and postoperative recovery in people with Lung Diseases and Total Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 16 Feb 2023. 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 Taiwan. 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?
difficulty of bronchoscopic approach (time frame: from bronchoscopic insertion to visualize vocal cords). 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?
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 16 Feb 2023.