Throat DisordersNCT02780518
Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery
A study testing Airvo in people with Throat Disorders, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to patients when they are paralysed under general anaesthesia. Their lungs are not moving, but the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Throat Disorders
- What is being tested?
- Airvo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2016to Jun 2017
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients undergoing elective microlaryngeal surgery requiring general anaesthesia and jet ventilation. They must have a physical status of the American Society of Anesthesiologists (ASA) grade I/II and age 21 years or older.
Who cannot join
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
- Patients with ASA grading of III and above are excluded from the study
- Patients needing a rapid sequence induction for rapid securement of the airway
- Pregnant women
- Patients below the age of 21 years old
Show all 9Show fewer
- Patients unfit to give consent
- Patients with nasal or sinus disease or problems
- Patients with infective laryngeal disease e.g. papillomatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery - Assessing Effectiveness of Oxygenation and Carbon Dioxide Clearance
Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to patients when they are paralysed under general anaesthesia. Their lungs are not moving, but the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'. The investigators will be using this for patients undergoing surgery for their throat.
Read the detailed description
Hypothesis:
Optiflow high flow nasal cannula (HFNC) oxygenation is a suitable technique for oxygenation and ventilation (apnoeic ventilation) for patients undergoing microlaryngeal surgery.
Aims:
- Measure continuous pulse oximetry (oxygenation) and intermittent subglottic catheter sampling of end tidal carbon dioxide levels (ventilation) in the distal trachea during HFNC oxygenation
- Measure intra-tracheal airway pressure during HFNC oxygenation
Methodology:
As a pilot study, the investigators will recruit up to 20 patients within a 12 month period scheduled for elective microlaryngeal surgery and high frequency jet ventilation. Standard monitoring and standard conduct of anaesthesia will be carried out: induction of general anaesthesia, insertion of a narrow catheter into the trachea and insertion of laryngeal mask airway. In addition, the study device (HFNC) will be placed into the entrance of the patient's nostrils. After removal of the laryngeal mask, HFNC oxygenation will commence. A surgical suspension laryngoscope will be inserted for microlaryngeal surgery (standard technique). The investigators will measure the adequacy of gas exchange, during of HFNC oxygenation and complications (cardiovascular, airway and respiratory). Data will be stored on a secure REDCap (Research Electronic Data Capture) system.
Importance:
HFNC oxygenation is a novel technique that depends on apnoeic oxygenation. Even though the patient is paralysed and not breathing, oxygenation and carbon dioxide clearance still occurs. This is due to the difference between the alveolar rates of oxygen removal and carbon dioxide excretion which generates a negative pressure gradient. Oxygenation of the patient is therefore due to the high inspiratory fraction of oxygen, apnoeic ventilation and the small continuous positive airway pressure caused by the high flow of gas. This pressure increases lung volume and recruits collapsed alveoli. Carbon dioxide clearance is due to gas mixing and flushing of the airway dead space. The additional humidification of the high flow oxygen prevents mucociliary damage of the airway.
HFNC has been shown beneficial in pre-oxygenation, oxygenation after extubation, and in the treatment of respiratory failure and heart failure. New uses in difficult airway management are now emerging. However, the main case series of HFNC use in difficult airways did not measure intra-operative airway pressures end tidal oxygen and carbon dioxide; these gases were only measured at the end of surgery and when a definitive airway was inserted. As far as the investigators are aware, there are no data on intra-operative, intra-tracheal airway pressures or oxygen or carbon dioxide during HFNC oxygenation. Our study aim is to fill this knowledge gap.
Potential benefits and risks:
The use of HFNC removes obstacles form the surgical field and this may make surgery easier and quicker to perform. Risks include: failed gas exchange, but this is minimized by abandoning HFNC oxygenation and instituting tracheal catheter jet ventilation via the in situ jet catheter (standard practice).
- Conditions
- Throat Disorders
- Being tested
- Airvo
- Keywords
- oxygen, carbon dioxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirvoDevice
Applying high flow nasal oxygen
| Study group | Role | What they receive |
|---|---|---|
| Airvo | Experimental | All patients scheduled for elective microlaryngeal surgery under general anaesthesia and subglottic high frequency jet ventilation Receives: Device: Airvo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%).
Continuous pulse oximetry will be monitored for participants during the study.
Measured: 30 minutes
Secondary outcomes (2)
Number of patients with inadequate carbon dioxide clearance (end tidal CO2>55 mmHg)
End tidal carbon dioxide will be measured by the sublgottic catheter already in situ in the trachea by continuous passive sampling and by intermittent low frequency jet ventilation
Measured: 30 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
The investigator will report the number of participants wtih adverse events that are related to treatment
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Airvo 2 not suitable for CO2 clearance, awaiting Optiflow THRIVE machine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Throat DisordersStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wong, MBBS FRCA, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780518
- Sponsor's protocol ID
- 1605 Airvo Optiflow
- Status last verified
- Apr 2017
- First submitted
- 12 May 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
PubMed 25388828Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PubMed 25866645
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery - Assessing Effectiveness of Oxygenation and Carbon Dioxide Clearance
- ClinicalTrials.gov ID
- NCT02780518
- Acronym / sponsor ID
- 1605 Airvo Optiflow
- Conditions
- Throat Disorders
- Keywords
- oxygen, carbon dioxide
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Airvo 2 not suitable for CO2 clearance, awaiting Optiflow THRIVE machine
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 May 2016 (estimated)
- 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.
Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to patients when they are paralysed under general anaesthesia. Their lungs are not moving, but the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'. The investigators will be using this for patients undergoing surgery for their throat.
Detailed description
Hypothesis:
Optiflow high flow nasal cannula (HFNC) oxygenation is a suitable technique for oxygenation and ventilation (apnoeic ventilation) for patients undergoing microlaryngeal surgery.
Aims:
- Measure continuous pulse oximetry (oxygenation) and intermittent subglottic catheter sampling of end tidal carbon dioxide levels (ventilation) in the distal trachea during HFNC oxygenation
- Measure intra-tracheal airway pressure during HFNC oxygenation
Methodology:
As a pilot study, the investigators will recruit up to 20 patients within a 12 month period scheduled for elective microlaryngeal surgery and high frequency jet ventilation. Standard monitoring and standard conduct of anaesthesia will be carried out: induction of general anaesthesia, insertion of a narrow catheter into the trachea and insertion of laryngeal mask airway. In addition, the study device (HFNC) will be placed into the entrance of the patient's nostrils. After removal of the laryngeal mask, HFNC oxygenation will commence. A surgical suspension laryngoscope will be inserted for microlaryngeal surgery (standard technique). The investigators will measure the adequacy of gas exchange, during of HFNC oxygenation and complications (cardiovascular, airway and respiratory). Data will be stored on a secure REDCap (Research Electronic Data Capture) system.
Importance:
HFNC oxygenation is a novel technique that depends on apnoeic oxygenation. Even though the patient is paralysed and not breathing, oxygenation and carbon dioxide clearance still occurs. This is due to the difference between the alveolar rates of oxygen removal and carbon dioxide excretion which generates a negative pressure gradient. Oxygenation of the patient is therefore due to the high inspiratory fraction of oxygen, apnoeic ventilation and the small continuous positive airway pressure caused by the high flow of gas. This pressure increases lung volume and recruits collapsed alveoli. Carbon dioxide clearance is due to gas mixing and flushing of the airway dead space. The additional humidification of the high flow oxygen prevents mucociliary damage of the airway.
HFNC has been shown beneficial in pre-oxygenation, oxygenation after extubation, and in the treatment of respiratory failure and heart failure. New uses in difficult airway management are now emerging. However, the main case series of HFNC use in difficult airways did not measure intra-operative airway pressures end tidal oxygen and carbon dioxide; these gases were only measured at the end of surgery and when a definitive airway was inserted. As far as the investigators are aware, there are no data on intra-operative, intra-tracheal airway pressures or oxygen or carbon dioxide during HFNC oxygenation. Our study aim is to fill this knowledge gap.
Potential benefits and risks:
The use of HFNC removes obstacles form the surgical field and this may make surgery easier and quicker to perform. Risks include: failed gas exchange, but this is minimized by abandoning HFNC oxygenation and instituting tracheal catheter jet ventilation via the in situ jet catheter (standard practice).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airvo | Experimental | Device: AirvoAll patients scheduled for elective microlaryngeal surgery under general anaesthesia and subglottic high frequency jet ventilation |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients undergoing elective microlaryngeal surgery requiring general anaesthesia and jet ventilation. They must have a physical status of the American Society of Anesthesiologists (ASA) grade I/II and age 21 years or older.
Key exclusion criteria (9 listed)
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
- Patients with ASA grading of III and above are excluded from the study
- Patients needing a rapid sequence induction for rapid securement of the airway
- Pregnant women
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 |
|---|---|---|
| AirvoApplying high flow nasal oxygen | Device | Airvo |
Primary outcome
Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%).
Time frame: 30 minutes
Continuous pulse oximetry will be monitored for participants during the study.
2 secondary outcomes
Number of patients with inadequate carbon dioxide clearance (end tidal CO2>55 mmHg)
Time frame: 30 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Background: PubMed 25388828Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
- Background: PubMed 25866645Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
- 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.
Patrick Wong, MBBS FRCA principal investigator
Singapore General 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 Airvo in people with Throat Disorders, run by Singapore General Hospital at 1 site in Singapore.
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 9 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: withdrawn, as of the sponsor's last update on 1 May 2017. 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 Singapore. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%). (time frame: 30 minutes). 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 NCT02780518, which also lists 2 linked publications.
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 1 May 2017.