Anesthesia Intubation ComplicationNCT03550924
Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Morbidly Obese
A study testing low flow passive oxygenation and high flow passive oxygenation in people with Anesthesia Intubation Complication and Anesthesia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Anesthesia Intubation Complication, Anesthesia
- What is being tested?
- low flow passive oxygenation and high flow passive oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jul 2018to 22 Jan 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- American Society of Anesthesiologists physical status classification class 2-3
- BMI > 40
- elective surgery under general anesthesia
Who cannot join
- expected difficult airway (El Ganzouri Risk Index > 6)
- oxygen saturation of less than 98% despite adequate preoxygenation,
- nasal obstruction
- smoker, more than 10 cigarettes per day
- chronic respiratory disease
- FEV1 (forced expiratory volume in one second) < 70%
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- elevated intracranial pressure
- unable to give informed consent
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Duration of Apnea Without Desaturation at Induction of Anesthesia in Morbidly Obese Patients Using "Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE)"
This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.
Read the detailed description
Background Providing safe anesthesia for surgery in obese patients requires specific consideration of the pathophysiological changes and respiratory complications are frequent. Anesthesia induction needs special attention in this patient population. A decrease in functional residual capacity (FRC) after induction of anesthesia dramatically shortens the duration of apnea without desaturation (DAWD) during which the airway can be secured.
Several measures such as positioning in a semi sitting position, preoxygenation with PEEP and passive insufflation of oxygen during laryngoscopy have been shown to prolong the DAWD. None of these measures is able to produce positive endexpiratory pressure (PEEP) during laryngoscopy which would counteract the loss of FRC and therefore prolong the DAWD further.
Transnasal humidified rapid insufflation ventilator exchange (THRIVE, also knowns as "high flow nasal oxygen therapy" and "heated and humidified nasal oxygen") devices have been used for several years in intensive care and are available from numerous vendors. With THRIVE, heated and humidified oxygen is insufflated via nasal prongs at a rate up to 120 l/minute and it has been shown that this creates levels of PEEP, proportional to the amount of gas flow. Using THRIVE during the apneic phase of anesthesia induction in obese patients might be superior compared to low flow oxygen techniques as THRIVE generates PEEP during laryngoscopy, which might counteract the loss of FRC and consequently might prolong the DAWD.
Aim of the project This project will investigate the DAWD when using THRIVE vs. low flow nasal oxygen at anesthesia induction in obese patients.
Hypothesis The duration of apnea without desaturation is longer in the "THRIVE" group compared to the "low flow oxygen" group.
Methods The study will be conducted as a single center, prospective, randomized, controlled trial at the Medical University of Vienna, Austria.
Forty adult patients of the ASA classification 2 and 3 with a BMI >40 undergoing elective surgery under general anesthesia will be included. Patients with expected difficult airway, patients with an oxygen saturation <98% despite preoxygenation, patients with nasal obstruction, smokers (>10 cigarettes/day), patients with chronic respiratory disease, patients unable to give consent, and pregnant or breastfeeding patients will be excluded.
Patients will be randomly assigned to one of two groups ("low flow oxygen" or "THRIVE" group) and anesthesia will be induced in a standardized fashion in both groups. During laryngoscopy, patients in the low flow group will receive nasal oxygen insufflation at a rate of 10 l/min and patients in the THRIVE group will receive oxygen at a rate of 120 l/min via a THRIVE system. Difficult laryngoscopy will be simulated and intubation will be performed as soon as oxygen saturation drops to 95%. The time from anesthesia induction until oxygen saturation drops to 95% (DAWD) will be measured.
- Conditions
- Anesthesia Intubation Complication, Anesthesia
- Being tested
- low flow passive oxygenation, high flow passive oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low flow passive oxygenationProcedure or surgery
low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs
high flow passive oxygenationProcedure or surgery
high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system
| Study group | Role | What they receive |
|---|---|---|
| Low flow Oxygen Group | Active comparator | low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs Receives: Procedure: low flow passive oxygenation |
| THRIVE Group | Experimental | high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system Receives: Procedure: high flow passive oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of safe apnea
The duration until oxygen saturation drops to 95% during laryngoscopy
Measured: duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.
Secondary outcomes (1)
blood gas analysis
arterial blood samples will be taken every 2 minutes after rocuronium was given until 2 minutes after intubation
Measured: every 2 minutes after rocuronium was given until 2 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start26 Jul 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective, single center, randomized, observer blinded, controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hamp, Medical University of Vienna
- Investigators
- Thomas Hamp, Doctor, Principal investigator, Department of Anaesthesia and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550924
- Sponsor's protocol ID
- 2270/2017
- Status last verified
- Sep 2020
- First submitted
- 28 May 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Duration of Apnea Without Desaturation at Induction of Anesthesia in Morbidly Obese Patients Using "Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE)"
- ClinicalTrials.gov ID
- NCT03550924
- Acronym / sponsor ID
- 2270/2017
- Conditions
- Anesthesia Intubation Complication, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 8 Jun 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.
This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.
Detailed description
Background Providing safe anesthesia for surgery in obese patients requires specific consideration of the pathophysiological changes and respiratory complications are frequent. Anesthesia induction needs special attention in this patient population. A decrease in functional residual capacity (FRC) after induction of anesthesia dramatically shortens the duration of apnea without desaturation (DAWD) during which the airway can be secured.
Several measures such as positioning in a semi sitting position, preoxygenation with PEEP and passive insufflation of oxygen during laryngoscopy have been shown to prolong the DAWD. None of these measures is able to produce positive endexpiratory pressure (PEEP) during laryngoscopy which would counteract the loss of FRC and therefore prolong the DAWD further.
Transnasal humidified rapid insufflation ventilator exchange (THRIVE, also knowns as "high flow nasal oxygen therapy" and "heated and humidified nasal oxygen") devices have been used for several years in intensive care and are available from numerous vendors. With THRIVE, heated and humidified oxygen is insufflated via nasal prongs at a rate up to 120 l/minute and it has been shown that this creates levels of PEEP, proportional to the amount of gas flow. Using THRIVE during the apneic phase of anesthesia induction in obese patients might be superior compared to low flow oxygen techniques as THRIVE generates PEEP during laryngoscopy, which might counteract the loss of FRC and consequently might prolong the DAWD.
Aim of the project This project will investigate the DAWD when using THRIVE vs. low flow nasal oxygen at anesthesia induction in obese patients.
Hypothesis The duration of apnea without desaturation is longer in the "THRIVE" group compared to the "low flow oxygen" group.
Methods The study will be conducted as a single center, prospective, randomized, controlled trial at the Medical University of Vienna, Austria.
Forty adult patients of the ASA classification 2 and 3 with a BMI >40 undergoing elective surgery under general anesthesia will be included. Patients with expected difficult airway, patients with an oxygen saturation <98% despite preoxygenation, patients with nasal obstruction, smokers (>10 cigarettes/day), patients with chronic respiratory disease, patients unable to give consent, and pregnant or breastfeeding patients will be excluded.
Patients will be randomly assigned to one of two groups ("low flow oxygen" or "THRIVE" group) and anesthesia will be induced in a standardized fashion in both groups. During laryngoscopy, patients in the low flow group will receive nasal oxygen insufflation at a rate of 10 l/min and patients in the THRIVE group will receive oxygen at a rate of 120 l/min via a THRIVE system. Difficult laryngoscopy will be simulated and intubation will be performed as soon as oxygen saturation drops to 95%. The time from anesthesia induction until oxygen saturation drops to 95% (DAWD) will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, single center, randomized, observer blinded, controlled
| Arm | Type | Receives |
|---|---|---|
| Low flow Oxygen Group | Active comparator | Procedure: low flow passive oxygenationlow flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs |
| THRIVE Group | Experimental | Procedure: high flow passive oxygenationhigh flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- American Society of Anesthesiologists physical status classification class 2-3
- BMI > 40
- elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- expected difficult airway (El Ganzouri Risk Index > 6)
- oxygen saturation of less than 98% despite adequate preoxygenation,
- nasal obstruction
- smoker, more than 10 cigarettes per day
- chronic 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 |
|---|---|---|
| low flow passive oxygenationlow flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs | Procedure or surgery | Low flow Oxygen Group |
| high flow passive oxygenationhigh flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system | Procedure or surgery | THRIVE Group |
Primary outcome
Duration of safe apnea
Time frame: duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.
The duration until oxygen saturation drops to 95% during laryngoscopy
1 secondary outcome
blood gas analysis
Time frame: every 2 minutes after rocuronium was given until 2 minutes after intubation
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 2 Sep 2020.
- Individual participant dataSharing planned: Undecided. not yet decided
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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.
Thomas Hamp, Doctor principal investigator
Department of Anaesthesia and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low flow passive oxygenation and high flow passive oxygenation in people with Anesthesia Intubation Complication and Anesthesia, run by Medical University of Vienna at 1 site in Austria.
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 4 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 Austria. 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?
Duration of safe apnea (time frame: duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.). 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 2 Sep 2020.