Apnea, PostanestheticoptilaryngoNCT03843580
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)
A study testing optiflow in people with Apnea, Postanesthetic and Desaturation of Blood, run by University Hospital, Caen at 2 sites in France.
Trial summary
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways. So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Postanesthetic, Desaturation of Blood, Apnea
- What is being tested?
- optiflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Apr 2019to 10 Feb 2022
- 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
- suspension laryngoscopy
Who cannot join
- THRIVE contraindication:
- epistaxis
- undrained pneumothorax
- Recent gastroesophageal surgery (1months)
- Skull Fractures
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.
So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.
- Conditions
- Apnea, Postanesthetic, Desaturation of Blood, Apnea, Anesthesia, Larynx Disease, Pharynx; Anomaly
- Being tested
- optiflow
- Keywords
- Time of apnea, Optiflow, Thrive, Apnea oxygenation, Suspension laryngoscopy, General Anesthesia, Oxygenation apnea
- Medical subject headings
- Butyrylcholinesterase deficiency, Apnea, Laryngeal Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optiflowDevice
we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard Allocation | No intervention | apnea without oxygenation like usual traitement |
| oxygenation optiflow | Experimental | optiflow oxygenation during apnea Receives: Device: optiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy
the number of patient who presented at least one desaturation during suspension laryngoscopy. An oxygen desaturation define like SpO2<96%
Measured: Two hours
Secondary outcomes (2)
hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
Decrease the number of Hypoxemia event define like SpO2<90%
Measured: 2 hours
side effect
decrease the number of side effects
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start23 Apr 2019
- Primary completion10 Feb 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, PostanestheticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Francois Baclesse
- Responsible party
- Sponsor
- Investigators
- Eleonore Mulac-Vauclair, Principal investigator, Centre Francois BaclessePierre-Emmanuel Marsan, Principal investigator, University Hospital, CaenKamga Herve, Principal investigator, University Hospital, CaenBoutros Mariam, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843580
- Sponsor's protocol ID
- 2019-A00112-55
- Acronym
- optilaryngo
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03843580
- Acronym / sponsor ID
- optilaryngo / 2019-A00112-55
- Conditions
- Apnea, Postanesthetic, Desaturation of Blood, Apnea, Anesthesia, Larynx Disease, Pharynx; Anomaly
- Keywords
- Time of apnea, Optiflow, Thrive, Apnea oxygenation, Suspension laryngoscopy, General Anesthesia, Oxygenation apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Francois Baclesse
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 18 Feb 2019 (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.
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.
So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Allocation | No intervention | –apnea without oxygenation like usual traitement |
| oxygenation optiflow | Experimental | Device: optiflowoptiflow oxygenation during apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- suspension laryngoscopy
Key exclusion criteria (5 listed)
- THRIVE contraindication:
- epistaxis
- undrained pneumothorax
- Recent gastroesophageal surgery (1months)
- Skull Fractures
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 |
|---|---|---|
| optiflowwe use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy | Device | oxygenation optiflow |
Primary outcome
desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy
Time frame: Two hours
the number of patient who presented at least one desaturation during suspension laryngoscopy. An oxygen desaturation define like SpO2<96%
2 secondary outcomes
hypoxemia (decrease the number of Hypoxemia event define like SpO2<90%)
Time frame: 2 hours
side effect
Time frame: 2 hours
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 18 Feb 2022.
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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.
Eleonore Mulac-Vauclair principal investigator
Centre Francois Baclesse
Pierre-Emmanuel Marsan principal investigator
University Hospital, Caen
Kamga Herve principal investigator
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optiflow in people with Apnea, Postanesthetic and Desaturation of Blood, run by University Hospital, Caen at 2 sites in France.
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 5 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
desaturation defined as the number of patient who presented at least one desaturation during suspension laryngoscopy (time frame: Two hours). 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 18 Feb 2022.