BronchoscopyNCT03086408
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy
A study testing THRIVE and Endotracheal tube or Supraglottic airway in people with Bronchoscopy, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- THRIVE and Endotracheal tube or Supraglottic airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 10 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for diagnostic bronchoscopy
Who cannot join
- Patients with significantly decreased myocardial function (ejection fraction < 50%)
- Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
- Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
- Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
- Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2.
- Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
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- Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
- Patients with skull base defects.
- Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
- Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 < 95%.
- Obese patients with BMI above 35 kg/m2.
- Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.
- Patients with hiatal hernia and full stomach patients.
- Patients on immunosuppressive medications.
- Patient's refusal to participate in the study.
- Patients who do not understand English or mentally handicapped.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
Official title: The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures
The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.
- Conditions
- Bronchoscopy
- Being tested
- THRIVE, Endotracheal tube or Supraglottic airway
- Keywords
- airway management, high flow nasal oxygen, high flow nasal cannula, THRIVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEDevice
active nasal oxygen delivery system
Endotracheal tube or Supraglottic airwayDevice
Plastic devices for mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| THRIVE | Experimental | high flow nasal oxygen Receives: Device: THRIVE |
| endotracheal tube or supraglottic airway | Active comparator | tracheal intubation or supraglottic airway device Receives: Device: Endotracheal tube or Supraglottic airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Measured: Duration of surgery (average approximately 1 hour)
Awakening/Extubation Time
Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Measured: Duration of surgery (average approximately 1 hour)
Time to Bronchoscope Placement in Trachea
Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.
Measured: Duration of surgery (average approximately 1 hour)
Number of Tracheal Bronchoscope Placements Required
Measured: Duration of surgery (average approximately 1 hour)
Duration of Procedure
Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.
Measured: Duration of surgery (average approximately 1 hour)
Secondary outcomes (5)
Time to Patient Being Alert and Oriented x 4
Recorded from patient's admission to the post-anesthesia care unit (PACU) to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.
Measured: Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time
From admission to recovery room, to discharge from recovery room
Measured: Duration of recovery room stay (average approximately 1 hour)
First Pain Score in Recovery Room
Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).
Measured: Duration of recovery room stay (average approximately 1 hour)
Discharge-ready Pain Score
Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).
Measured: Day of discharge (up to 2 minutes)
Analgesic Consumption
Analgesic consumption was measured in oral morphine milligram equivalents (MME)
Measured: Recovery room to 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start9 May 2017
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Nekhendzy, Stanford University
- Investigators
- Vladimir Nekhendzy, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086408
- Sponsor's protocol ID
- 40295
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2017
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures
- ClinicalTrials.gov ID
- NCT03086408
- Acronym / sponsor ID
- 40295
- Conditions
- Bronchoscopy
- Keywords
- airway management, high flow nasal oxygen, high flow nasal cannula, THRIVE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 23 Jun 2020
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 investigate whether diagnostic bronchoscopy can be safely and potentially more effectively performed without the use of tracheal intubation or a supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE: Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE | Experimental | Device: THRIVEhigh flow nasal oxygen |
| endotracheal tube or supraglottic airway | Active comparator | Device: Endotracheal tube or Supraglottic airwaytracheal intubation or supraglottic airway device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for diagnostic bronchoscopy
Key exclusion criteria (17 listed)
- Patients with significantly decreased myocardial function (ejection fraction < 50%)
- Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
- Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
- Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
- Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2.
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 |
|---|---|---|
| THRIVEactive nasal oxygen delivery system | Device | THRIVE |
| Endotracheal tube or Supraglottic airwayPlastic devices for mechanical ventilation | Device | endotracheal tube or supraglottic airway |
Primary outcome
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
Time frame: Duration of surgery (average approximately 1 hour)
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Awakening/Extubation Time
Time frame: Duration of surgery (average approximately 1 hour)
Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Time to Bronchoscope Placement in Trachea
Time frame: Duration of surgery (average approximately 1 hour)
Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.
Number of Tracheal Bronchoscope Placements Required
Time frame: Duration of surgery (average approximately 1 hour)
Duration of Procedure
Time frame: Duration of surgery (average approximately 1 hour)
Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.
5 secondary outcomes
Time to Patient Being Alert and Oriented x 4
Time frame: Duration of surgery (average approximately 1 hour)
Recovery Room Discharge-ready Time
Time frame: Duration of recovery room stay (average approximately 1 hour)
First Pain Score in Recovery Room
Time frame: Duration of recovery room stay (average approximately 1 hour)
Discharge-ready Pain Score
Time frame: Day of discharge (up to 2 minutes)
Analgesic Consumption
Time frame: Recovery room to 7th postoperative day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Vladimir Nekhendzy, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE and Endotracheal tube or Supraglottic airway in people with Bronchoscopy, run by Stanford University at 1 site in United States.
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 17 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 17 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2) (time frame: Duration of surgery (average approximately 1 hour)). The study lists 5 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 17 Jul 2020.