ApneaNCT03797859
THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.
An observational study of Apnea and Ventilation Therapy; Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apnea, Ventilation Therapy; Complications, Respiratory Acidosis
- What is being tested?
- Apneic ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 Jan 2019to 1 Jun 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory.
Who may be able to join
- Adult (age over 18 years)
- Elective surgery where intubation is not mandatory
- The patient can understand the information about the study and give their informed written consent of participation
Who cannot join
- ASA (American Society of Anaesthesiologists class) > 3
- NYHA (New York Heart Association class) > 2
- BMI > 30 kg/m2
- Symptomatic respiratory disease
- Symptomatic cardiac disease
- Evidence of arteriosclerotic disease
Show all 10Show fewer
- Neuromuscular disease
- Pregnancy
- Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score > 4)
- Known or suspected nasal congestion/stenosis or catharalia
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, Hoevdstaden, 2100
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, 2100
About this study
Official title: Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.
We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.
Read the detailed description
THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.
Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed.
We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE.
- Being tested
- Apneic ventilation
- Medical subject headings
- Apnea, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic ventilationProcedure or surgery
Ventilation by THRIVE
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory acidosis
Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study
Measured: Max. 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start8 Jan 2019
- Primary completion1 May 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael S Kristensen, MD, Principal investigator, Senior consultant, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797859
- Sponsor's protocol ID
- H-18017844
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.
- ClinicalTrials.gov ID
- NCT03797859
- Acronym / sponsor ID
- H-18017844
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 9 Jan 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.
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.
We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.
Detailed description
THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.
Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed.
We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory.
Key inclusion criteria (3 listed)
- Adult (age over 18 years)
- Elective surgery where intubation is not mandatory
- The patient can understand the information about the study and give their informed written consent of participation
Key exclusion criteria (10 listed)
- ASA (American Society of Anaesthesiologists class) > 3
- NYHA (New York Heart Association class) > 2
- BMI > 30 kg/m2
- Symptomatic respiratory disease
- Symptomatic cardiac disease
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 |
|---|---|---|
| Apneic ventilationVentilation by THRIVE | Procedure or surgery | – |
Primary outcome
Respiratory acidosis
Time frame: Max. 60 minutes
Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Apnea
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
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.
Michael S Kristensen, MD principal investigator
Senior consultant, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea and Ventilation Therapy; Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
Respiratory acidosis (time frame: Max. 60 minutes). 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 23 Jan 2019.