High Flow Oxygen in Rapid Sequence InductionTHRIVE/RSI 1NCT02777840
High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients
A study testing face mask oxygen and High flow oxygen in people with High Flow Oxygen in Rapid Sequence Induction and Airway Morbidity, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Flow Oxygen in Rapid Sequence Induction, Airway Morbidity
- What is being tested?
- face mask oxygen and High flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Mar 2018
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Emergency patients needing rapid sequence induction for surgery
- ≥ 16 years
- Able to give consent
Who cannot join
- Patients age under 16 years
- Inability to give consent
- Severe respiratory disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Georges Hospital NHS Trust
London, sw17 0qt
Fauzia Mir, fmir@nhs.net
Lucy Parker, 0208 266 6397, laprker@sgul.ac.uk
About this study
High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.
Read the detailed description
The investigators intend to do the study using high flow oxygen for all emergency cases needing rapid sequence induction. As part of the study the Investigators will measure the oxygen levels in the blood gas sample of the patient and the heart rate of anesthetist in charge of the airway management. After the airway is secured the time for desaturation will be noted.
- Being tested
- face mask oxygen, High flow oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face mask oxygenDevice
oxygen given by face mask as per routine practice
High flow oxygenDevice
High flow oxygen given via optiflo machine / device
| Study group | Role | What they receive |
|---|---|---|
| Face mask group | Active comparator | Patients will be given oxygen via face mask as per routine practice, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. Receives: Device: face mask oxygen |
| THRIVE group | Active comparator | Patients will be given oxygen via high flow oxygen in Optiflo, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. Receives: Device: High flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen levels in blood gas sample
Oxygen levels in blood gas sample after the airway is secured
Measured: intraoperative
Secondary outcomes (2)
time to desaturation
after airway is secured time will be noted for oxygen levels to fall to 92% before the ventilation is started.
Measured: intraoperative or 10 minutes after intubation
heart rate of anaesthetist performing the intubation
Measured: During the process of induction of anaesthesia and intubation upto 5 minutes post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Oxygen in Rapid Sequence InductionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fauzia Mir, Principal investigator, St Georges hospital NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777840
- Sponsor's protocol ID
- 15/LO/0277
- Acronym
- THRIVE/RSI 1
- Status last verified
- Oct 2017
- First submitted
- 13 May 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: As per guidelines
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients
- ClinicalTrials.gov ID
- NCT02777840
- Acronym / sponsor ID
- THRIVE/RSI 1 / 15/LO/0277
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 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.
High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.
Detailed description
The investigators intend to do the study using high flow oxygen for all emergency cases needing rapid sequence induction. As part of the study the Investigators will measure the oxygen levels in the blood gas sample of the patient and the heart rate of anesthetist in charge of the airway management. After the airway is secured the time for desaturation will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face mask group | Active comparator | Device: face mask oxygenPatients will be given oxygen via face mask as per routine practice, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. |
| THRIVE group | Active comparator | Device: High flow oxygenPatients will be given oxygen via high flow oxygen in Optiflo, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency patients needing rapid sequence induction for surgery
- ≥ 16 years
- Able to give consent
Key exclusion criteria (3 listed)
- Patients age under 16 years
- Inability to give consent
- Severe respiratory 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 |
|---|---|---|
| face mask oxygenoxygen given by face mask as per routine practice | Device | Face mask group |
| High flow oxygenHigh flow oxygen given via optiflo machine / device | Device | THRIVE group |
Primary outcome
Oxygen levels in blood gas sample
Time frame: intraoperative
Oxygen levels in blood gas sample after the airway is secured
2 secondary outcomes
time to desaturation
Time frame: intraoperative or 10 minutes after intubation
heart rate of anaesthetist performing the intubation
Time frame: During the process of induction of anaesthesia and intubation upto 5 minutes post intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: Yes. As per guidelines
Related trials for High Flow Oxygen in Rapid Sequence Induction
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
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.
Fauzia Mir principal investigator
St Georges hospital NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face mask oxygen and High flow oxygen in people with High Flow Oxygen in Rapid Sequence Induction and Airway Morbidity, run by St George's, University of London at 1 site in United Kingdom.
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 3 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 5 Oct 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 United Kingdom. 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?
Contact Lucy Parker (0208 266 6397 ext. 6397, lparker@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen levels in blood gas sample (time frame: intraoperative). 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 5 Oct 2017.