Apneic OxygenationNCT03629353
The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange During Laryngeal Microsurgery
A study testing endotracheal intubation and high flow nasal cannula in people with Apneic Oxygenation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- endotracheal intubation and high flow nasal cannula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2018to 24 Feb 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing laryngeal microsurgery
- ASA class I-III
Who cannot join
- patients scheduled for laryngeal microsurgery using CO2 laser
- patients with increased intracranial pressure
- patients with skull base defect
- patients with chronic obstructive pulmonary disease
- patients with pulmonary hypertension
- patients requiring rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.
However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.
Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.
Read the detailed description
Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.
On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.
The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.
- Conditions
- Apneic Oxygenation
- Being tested
- endotracheal intubation, high flow nasal cannula
- Keywords
- airway management, high flow nasal cannula, laryngeal microsurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubationProcedure or surgery
After preoxygenation with FiO2 1.0 and flow rate of 8 L/min for 3 minutes, the enrolled patients will be intubated with endotracheal tube and maintained oxygenation during surgery.
high flow nasal cannulaProcedure or surgery
After preoxygenation with 100% oxygen through high flow nasal cannula for 3 minutes, the enrolled patients will be maintained intubationless oxygenation with flow rate of 70 L/min during surgery.
| Study group | Role | What they receive |
|---|---|---|
| intubation group | Experimental | The enrolled patients will be oxygenated by endotracheal tube during operation. Receives: Procedure: endotracheal intubation |
| THRIVE group | Experimental | The enrolled patients will be oxygenated by intubationless high flow nasal cannula during operation. Receives: Procedure: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowest oxygen saturation
lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery
Measured: from the time of starting laryngeal microsurgery till the end of the surgery
Secondary outcomes (2)
lowest oxygen reserve index
lowest oxygen reserve index monitored during laryngeal microsurgery
Measured: from the time of starting laryngeal microsurgery till the end of the surgery
highest transcutaneous partial pressure of carbon dioxide
highest transcutaneous partial pressure of carbon dioxide monitored during laryngeal microsurgery
Measured: from the time of starting laryngeal microsurgery till the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start17 Aug 2018
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
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 Apneic OxygenationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629353
- Sponsor's protocol ID
- THRIVE during LMS
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Min SH, Yoon H, Huh G, Kwon SK, Seo JH, Cho YJ. Efficacy of high-flow nasal oxygenation compared with tracheal intubation for oxygenation during laryngeal microsurgery: a randomised non-inferiority study. Br J Anaesth. 2022 Jan;128(1):207-213. doi: 10.1016/j.bja.2021.09.016. Epub 2021 Oct 20.
PubMed 34688473
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03629353
- Acronym / sponsor ID
- THRIVE during LMS
- Conditions
- Apneic Oxygenation
- Keywords
- airway management, high flow nasal cannula, laryngeal microsurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 14 Aug 2018 (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.
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.
However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.
Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.
Detailed description
Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.
On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.
The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intubation group | Experimental | Procedure: endotracheal intubationThe enrolled patients will be oxygenated by endotracheal tube during operation. |
| THRIVE group | Experimental | Procedure: high flow nasal cannulaThe enrolled patients will be oxygenated by intubationless high flow nasal cannula during operation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing laryngeal microsurgery
- ASA class I-III
Key exclusion criteria (6 listed)
- patients scheduled for laryngeal microsurgery using CO2 laser
- patients with increased intracranial pressure
- patients with skull base defect
- patients with chronic obstructive pulmonary disease
- patients with pulmonary hypertension
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 |
|---|---|---|
| endotracheal intubationAfter preoxygenation with FiO2 1.0 and flow rate of 8 L/min for 3 minutes, the enrolled patients will be intubated with endotracheal tube and maintained oxygenation during surgery. | Procedure or surgery | intubation group |
| high flow nasal cannulaAfter preoxygenation with 100% oxygen through high flow nasal cannula for 3 minutes, the enrolled patients will be maintained intubationless oxygenation with flow rate of 70 L/min during surgery. | Procedure or surgery | THRIVE group |
Primary outcome
lowest oxygen saturation
Time frame: from the time of starting laryngeal microsurgery till the end of the surgery
lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery
2 secondary outcomes
lowest oxygen reserve index
Time frame: from the time of starting laryngeal microsurgery till the end of the surgery
highest transcutaneous partial pressure of carbon dioxide
Time frame: from the time of starting laryngeal microsurgery till the end of the surgery
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 20 Nov 2020.
- Derived from this study: PubMed 34688473Min SH, Yoon H, Huh G, Kwon SK, Seo JH, Cho YJ. Efficacy of high-flow nasal oxygenation compared with tracheal intubation for oxygenation during laryngeal microsurgery: a randomised non-inferiority study. Br J Anaesth. 2022 Jan;128(1):207-213. doi: 10.1016/j.bja.2021.09.016. Epub 2021 Oct 20.
- Individual participant dataSharing planned: Undecided
Related trials for Apneic Oxygenation
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
Not yet recruiting
Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
Healthy, Healthy Adult
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.
Youn Joung Cho, MD principal investigator
Seoul National 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 endotracheal intubation and high flow nasal cannula in people with Apneic Oxygenation, run by Seoul National University Hospital at 1 site in South Korea.
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 6 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 20 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 South Korea. 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?
lowest oxygen saturation (time frame: from the time of starting laryngeal microsurgery till the end of the surgery). 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 NCT03629353, 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 20 Nov 2020.