IntubationPre-AeRATENCT03396094
Pre- and Apnoeic Oxygenation for RSI in ED
A study testing High-flow nasal cannulae (HFNC) oxygenation and Non-rebreather mask and standard nasal cannula in people with Intubation and Oxygen Inhalation Therapy, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Critically ill patients may need support for breathing by means of intubation, which is placement of a breathing tube into the windpipe. Rapid sequence intubation (RSI) is a method commonly used and is performed by administering medications to induce coma and muscle paralysis, followed by intubation to allow the… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Intubation, Oxygen Inhalation Therapy
- What is being tested?
- High-flow nasal cannulae (HFNC) oxygenation and Non-rebreather mask and standard nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSingapore
- Study dates
- 7 May 2018to 31 Jul 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 21 years and above, who require RSI due to medical, surgical and traumatic conditions, in the Emergency Departments of NUH and Ng Teng Fong General Hospital (NTFGH)
Who cannot join
- Patients with "do-not-resuscitate" orders
- Crash, awake or delayed sequence intubations
- Patients requiring non-invasive positive pressure ventilation
- Cardiac arrest
- Clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes nasal cannula placement
- Vulnerable patient populations (e.g. pregnant women, prisoners)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre- and Apnoeic High Flow Oxygenation for RApid Sequence Intubation in The Emergency Department (Pre-AeRATE): a Multicentre Randomised Controlled Trial
Critically ill patients may need support for breathing by means of intubation, which is placement of a breathing tube into the windpipe. Rapid sequence intubation (RSI) is a method commonly used and is performed by administering medications to induce coma and muscle paralysis, followed by intubation to allow the ventilator to provide oxygen into the lungs. This procedure may be filled with potential complications.
During RSI, the patient stops spontaneous breathing after medically induced muscle paralysis occurs. Adequate oxygenation before and during paralysis is crucial to increase the reserves and prolong the time that oxygen levels in the blood remain above 90%, called the safe apnoea period. If the oxygen reserves are insufficient, the blood oxygen level will drop and can lead to permanent brain damage or even death.
This study aims to explore if delivering high-flow humidified oxygen at 60L/min via the nostrils would be superior to current methods of mask ventilation at 15L/min and nasal cannula at 15L/min, before and during paralysis respectively. If successful, this new method would allow for a longer safe apnoeic period and increase the chances for doctors to perform intubation successfully without the blood oxygen dropping below 90%.
Read the detailed description
Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or prolonged vegetative state requiring long-term institutionalisation.
Preliminary data from our emergency department (ED) airway registry revealed that 15% of patients experienced desaturation during intubation despite employing current best practices during RSI. In this multicentre randomised controlled trial in the ED, we aim to test the hypothesis that use of humidified high flow oxygenation via nasal cannula (HFNC) at 60L/min maintains higher oxygen saturation compared with current usual care using non-rebreather mask for preoxygenation and provides superior apnoeic oxygenation compared to the typical practice of 15L/min via standard nasal cannula.
The main goal of the study would be to improve on the lowest oxygen saturation during intubation, and thereby increase the safe apnoeic time during RSI. We plan to enrol adult patients who require rapid sequence intubation due to medical, surgical or traumatic conditions in the EDs of National University Hospital and Ng Teng Fong General Hospital.
Eligible patients will undergo block randomisation at equal ratio into 2 possible treatment combinations of pre-oxygenation and apnoeic oxygenation. The primary endpoint will be the lowest oxygen saturation achieved from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected for the first intubation attempt.
Higher failure rates for intubation in unfasted patients in the ED compared to fasted patients in elective settings increase the risk of aspiration if re-oxygenation is required with bag-valve-mask ventilation. Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care and translate to better outcomes for patients.
- Conditions
- Intubation, Oxygen Inhalation Therapy
- Being tested
- High-flow nasal cannulae (HFNC) oxygenation, Non-rebreather mask and standard nasal cannula
- Keywords
- high flow oxygenation, rapid sequence intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulae (HFNC) oxygenationDevice
Also called AIRVO™ 2 Humidifier with Integrated Flow Generator
Delivery of 60L/min of supplemental oxygen for pre-oxygenation and apnoeic oxygenation during rapid sequence intubation using the AIRVO™ 2 Humidifier with Integrated Flow Generator (Fisher \& Paykel Healthcare, Auckland, New Zealand)
Non-rebreather mask and standard nasal cannulaDevice
Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | High-flow nasal cannula oxygenation at 60L/min for pre-oxygenation and apnoeic oxygenation Receives: Device: High-flow nasal cannulae (HFNC) oxygenation |
| Control | Active comparator | Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min Receives: Device: Non-rebreather mask and standard nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest SpO2 achieved during first intubation attempt
Lowest SpO2 achieved during first intubation attempt which is defined as first attempt to insert endotracheal tube into oropharynx
Measured: From time of administration of paralytic agent until quantitative ETCO2 is detected post-intubation up to 45 minutes
Secondary outcomes (5)
Number of attempts at intubation
Number of attempts until successful intubation as indicated by detection of quantitative ETCO2
Measured: Number of attempts required until successful intubation up to 45 minutes or termination of procedure, whichever is earlier
Safe apnoea time during intubation
Duration of apnoea where SpO2 remains ≥ 90%
Measured: From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes
Incidence of SpO2 < 90%
Incidence of SpO2 < 90% during apnoea
Measured: From start of paralysis to successful intubation up to 45 minutes
Peri-intubation adverse events
Peri-intubation adverse events defined as hypotension, hypertension, tachycardia, bradycardia, regurgitation, aspiration, cardiac arrhythmia, cardiac arrest during RSI, oropharynx or dental trauma
Measured: From induction to 15 minutes after intubation
Length of time to successful intubation
Time taken from induction to successful intubation attempt
Measured: From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start7 May 2018
- Primary completion1 Jan 2020
- Study completion31 Jul 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 IntubationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Model description
- This study consists of 2 arms (intervention and control) of parallel design. The intervention arm will receive high flow nasal cannula (HFNC) oxygenation at 60L/min for pre- and apnoeic oxygenation while the control arm will receive pre-oxygenation via non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Mui Teng Chua, MBBS, MPH, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396094
- Sponsor's protocol ID
- CNIG17may007
- Acronym
- Pre-AeRATE
- Status last verified
- Mar 2021
- First submitted
- 1 Jan 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chua MT, Khan FA, Ng WM, Lu Q, Low MJW, Yau YW, Punyadasa A, Kuan WS. Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial. Trials. 2019 Apr 4;20(1):195. doi: 10.1186/s13063-019-3305-8.
PubMed 30947740
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Apnoeic High Flow Oxygenation for RApid Sequence Intubation in The Emergency Department (Pre-AeRATE): a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03396094
- Acronym / sponsor ID
- Pre-AeRATE / CNIG17may007
- Conditions
- Intubation, Oxygen Inhalation Therapy
- Keywords
- high flow oxygenation, rapid sequence intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, Singapore Clinical Research Institute
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 Jan 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.
Critically ill patients may need support for breathing by means of intubation, which is placement of a breathing tube into the windpipe. Rapid sequence intubation (RSI) is a method commonly used and is performed by administering medications to induce coma and muscle paralysis, followed by intubation to allow the ventilator to provide oxygen into the lungs. This procedure may be filled with potential complications.
During RSI, the patient stops spontaneous breathing after medically induced muscle paralysis occurs. Adequate oxygenation before and during paralysis is crucial to increase the reserves and prolong the time that oxygen levels in the blood remain above 90%, called the safe apnoea period. If the oxygen reserves are insufficient, the blood oxygen level will drop and can lead to permanent brain damage or even death.
This study aims to explore if delivering high-flow humidified oxygen at 60L/min via the nostrils would be superior to current methods of mask ventilation at 15L/min and nasal cannula at 15L/min, before and during paralysis respectively. If successful, this new method would allow for a longer safe apnoeic period and increase the chances for doctors to perform intubation successfully without the blood oxygen dropping below 90%.
Detailed description
Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or prolonged vegetative state requiring long-term institutionalisation.
Preliminary data from our emergency department (ED) airway registry revealed that 15% of patients experienced desaturation during intubation despite employing current best practices during RSI. In this multicentre randomised controlled trial in the ED, we aim to test the hypothesis that use of humidified high flow oxygenation via nasal cannula (HFNC) at 60L/min maintains higher oxygen saturation compared with current usual care using non-rebreather mask for preoxygenation and provides superior apnoeic oxygenation compared to the typical practice of 15L/min via standard nasal cannula.
The main goal of the study would be to improve on the lowest oxygen saturation during intubation, and thereby increase the safe apnoeic time during RSI. We plan to enrol adult patients who require rapid sequence intubation due to medical, surgical or traumatic conditions in the EDs of National University Hospital and Ng Teng Fong General Hospital.
Eligible patients will undergo block randomisation at equal ratio into 2 possible treatment combinations of pre-oxygenation and apnoeic oxygenation. The primary endpoint will be the lowest oxygen saturation achieved from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected for the first intubation attempt.
Higher failure rates for intubation in unfasted patients in the ED compared to fasted patients in elective settings increase the risk of aspiration if re-oxygenation is required with bag-valve-mask ventilation. Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care and translate to better outcomes for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of 2 arms (intervention and control) of parallel design. The intervention arm will receive high flow nasal cannula (HFNC) oxygenation at 60L/min for pre- and apnoeic oxygenation while the control arm will receive pre-oxygenation via non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: High-flow nasal cannulae (HFNC) oxygenationHigh-flow nasal cannula oxygenation at 60L/min for pre-oxygenation and apnoeic oxygenation |
| Control | Active comparator | Device: Non-rebreather mask and standard nasal cannulaPre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 21 years and above, who require RSI due to medical, surgical and traumatic conditions, in the Emergency Departments of NUH and Ng Teng Fong General Hospital (NTFGH)
Key exclusion criteria (6 listed)
- Patients with "do-not-resuscitate" orders
- Crash, awake or delayed sequence intubations
- Patients requiring non-invasive positive pressure ventilation
- Cardiac arrest
- Clinical suspicion or confirmed diagnosis of base of skull fractures or severe facial trauma that precludes nasal cannula placement
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 |
|---|---|---|
| High-flow nasal cannulae (HFNC) oxygenationAlso: AIRVO™ 2 Humidifier with Integrated Flow GeneratorDelivery of 60L/min of supplemental oxygen for pre-oxygenation and apnoeic oxygenation during rapid sequence intubation using the AIRVO™ 2 Humidifier with Integrated Flow Generator (Fisher \& Paykel Healthcare, Auckland, New Zealand) | Device | Intervention |
| Non-rebreather mask and standard nasal cannulaPre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min | Device | Control |
Primary outcome
Lowest SpO2 achieved during first intubation attempt
Time frame: From time of administration of paralytic agent until quantitative ETCO2 is detected post-intubation up to 45 minutes
Lowest SpO2 achieved during first intubation attempt which is defined as first attempt to insert endotracheal tube into oropharynx
5 secondary outcomes
Number of attempts at intubation
Time frame: Number of attempts required until successful intubation up to 45 minutes or termination of procedure, whichever is earlier
Safe apnoea time during intubation
Time frame: From start of paralysis to time when SpO2 drops to less than 90% up to 45 minutes
Incidence of SpO2 < 90%
Time frame: From start of paralysis to successful intubation up to 45 minutes
Peri-intubation adverse events
Time frame: From induction to 15 minutes after intubation
Length of time to successful intubation
Time frame: From induction until successful intubation as confirmed by detection of quantitative ETCO2 up to 45 minutes
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 3 Mar 2021.
- Derived from this study: PubMed 30947740Chua MT, Khan FA, Ng WM, Lu Q, Low MJW, Yau YW, Punyadasa A, Kuan WS. Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial. Trials. 2019 Apr 4;20(1):195. doi: 10.1186/s13063-019-3305-8.
- 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.
Mui Teng Chua, MBBS, MPH principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannulae (HFNC) oxygenation and Non-rebreather mask and standard nasal cannula in people with Intubation and Oxygen Inhalation Therapy, run by National University Hospital, Singapore 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 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 3 Mar 2021. 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 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 SpO2 achieved during first intubation attempt (time frame: From time of administration of paralytic agent until quantitative ETCO2 is detected post-intubation up to 45 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 NCT03396094, 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 3 Mar 2021.