Compare Preoxygenation Methods in Bariatric PatientsNCT04965610
Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.
A study testing Preoxygenation with High Flow Nasal Cannula and Preoxygenation via face mask in people with Compare Preoxygenation Methods in Bariatric Patients, run by Staedtisches Klinikum Karlsruhe.
Trial summary
To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Compare Preoxygenation Methods in Bariatric Patients
- What is being tested?
- Preoxygenation with High Flow Nasal Cannula and Preoxygenation via face mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 18
- elective bariatric surgery
- written consent
Who cannot join
- preexisting lung diseases, congenital heart diseases
- known difficult airway
- SpO2 < 92% under ambient air conditions
- known diaphragmal hernia
- clinically relevant reflux
Trial locations and contacts
No sites are listed yet.
Franz Kehl, Prof. contact
About this study
To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional preoxygenation with face mask. Primary endpoint will be the time during which spO2 > 92 %. Secondary endpoint will be paCO2.
- Being tested
- Preoxygenation with High Flow Nasal Cannula, Preoxygenation via face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoxygenation with High Flow Nasal CannulaOther
Preoxygenation for 5 minutes via High Flow Nasal Cannula. After induction of anaesthesia apnoeic oxygenation with HFNC
Preoxygenation via face maskOther
Preoxygenation for 5 minutes via face mask. After induction of anaesthesia apnoeic oxygenation with tight fitting face mask
| Study group | Role | What they receive |
|---|---|---|
| Preoxygenation via THRIVE/High Flow Nasal Cannula | Experimental | Patients receive preoxygenation for induction of general anaesthesia via High Flow Nasal Cannula for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows. Receives: Other: Preoxygenation with High Flow Nasal Cannula |
| Preoxygenation via face mask (PROX) | Active comparator | Patients receive preoxygenation for induction of general anaesthesia via tight fitting face mask for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows. Receives: Other: Preoxygenation via face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normoxia time SpO2 > 92%
Time in which the SpO2 remains > 92% while patient is apnoeic
Measured: 10 Minutes after induction
Secondary outcomes (1)
paCO2
Increase in arterial CO2 during Apnoea
Measured: 10 Minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Preoxygenation Methods in Bariatric PatientsStudies 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
- Model description
- Two groups of patients. One receiving preoxygenation via High Flow Nasal Cannula and one group receiving preoxygenation via face mask
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staedtisches Klinikum Karlsruhe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Jugl, Staedtisches Klinikum Karlsruhe
- Investigators
- Joachim Jugl, Principal investigator, Senior Resident AnaesthesiaFranz Kehl, Prof., Study director, Head of Department of Anaesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965610
- Sponsor's protocol ID
- 070720211
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.
- ClinicalTrials.gov ID
- NCT04965610
- Acronym / sponsor ID
- 070720211
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Staedtisches Klinikum KarlsruheUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jul 2021 (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.
To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional preoxygenation with face mask. Primary endpoint will be the time during which spO2 > 92 %. Secondary endpoint will be paCO2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients. One receiving preoxygenation via High Flow Nasal Cannula and one group receiving preoxygenation via face mask
| Arm | Type | Receives |
|---|---|---|
| Preoxygenation via THRIVE/High Flow Nasal Cannula | Experimental | Other: Preoxygenation with High Flow Nasal CannulaPatients receive preoxygenation for induction of general anaesthesia via High Flow Nasal Cannula for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows. |
| Preoxygenation via face mask (PROX) | Active comparator | Other: Preoxygenation via face maskPatients receive preoxygenation for induction of general anaesthesia via tight fitting face mask for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18
- elective bariatric surgery
- written consent
Key exclusion criteria (5 listed)
- preexisting lung diseases, congenital heart diseases
- known difficult airway
- SpO2 < 92% under ambient air conditions
- known diaphragmal hernia
- clinically relevant reflux
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 |
|---|---|---|
| Preoxygenation with High Flow Nasal CannulaPreoxygenation for 5 minutes via High Flow Nasal Cannula. After induction of anaesthesia apnoeic oxygenation with HFNC | Other | Preoxygenation via THRIVE/High Flow Nasal Cannula |
| Preoxygenation via face maskPreoxygenation for 5 minutes via face mask. After induction of anaesthesia apnoeic oxygenation with tight fitting face mask | Other | Preoxygenation via face mask (PROX) |
Primary outcome
Normoxia time SpO2 > 92%
Time frame: 10 Minutes after induction
Time in which the SpO2 remains > 92% while patient is apnoeic
1 secondary outcome
paCO2
Time frame: 10 Minutes after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
Franz Kehl, Prof. contact
Joachim Jugl principal investigator
Senior Resident Anaesthesia
Franz Kehl, Prof. study director
Head of Department of Anaesthesia and Intensive Care
Questions about this trial
What is this clinical trial studying?
A study testing Preoxygenation with High Flow Nasal Cannula and Preoxygenation via face mask in people with Compare Preoxygenation Methods in Bariatric Patients, run by Staedtisches Klinikum Karlsruhe.
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 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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Joachim Jugl (004972197467846, Joachim.Jugl@klinikum-karlsruhe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normoxia time SpO2 > 92% (time frame: 10 Minutes after induction). 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 16 Jul 2021.