Adverse EffectNCT03723109
Airway Management During TCI vs RSI Anesthesia Induction
An observational study of Adverse Effect and Anesthesia, run by Umeå University at 1 site in Sweden.
Trial summary
The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Effect, Anesthesia, Airway Complication of Anesthesia
- What is being tested?
- Induction of anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 29 Oct 2018to 31 May 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cohort, electively scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) and minor general abdominal surgery.
Who may be able to join
- signed informed consent
- BMI < 35 kg/m2
- preoperative assessment accepted by consultant anesthesiologist
- scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) or minor general abdominal surgery.
Who cannot join
- not signed consent
- instable angina pectoris
- severe bronchial asthma
- severe chronic obstructive pulmonary disease
- dementia
- severe heart valve disease
- severe renal failure
- body mass index > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Airway Management and Safety Aspects During Target Controlled Infusion (TCI) Compared to Rapid Sequence Induction (RSI) of Anesthesia in Non-cardiac Surgery
The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.
Read the detailed description
The aims of this study are to evaluate and compare feasibility of airway management and risk for desaturation during standardized target controlled infusion (TCI) and rapid sequence induction (RSI) of anesthesia. A conventional way to induce anesthesia, i.e. manual injection of anesthetics, may be more accurate and predictable compared to dosing regimes based on complex mathematical algorithms used in TCI-systems. In addition, today many different models are presented and there is no consensus which kind of TCI-algorithm should be used universally. Moreover, dosing algorithms are most complex and challenging in underweight and morbid obesity. There are many publications on this field, but no data of feasibility of airway management can be found. Indeed, RSI induction is traditionally blamed to be risky and not recommended as a first choice.
- Being tested
- Induction of anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of anesthesiaProcedure or surgery
Also called Anesthesia induction
Standardized TCI and RSI anesthesia induction
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety time for apnea
measurement of length of period for apnea during TCI and RSI induction by a timer
Measured: 10min
Secondary outcomes (1)
Duration of spontaneous breathing
measurement of duration of spontaneous breathing during TCI and RSI induction by a timer
Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start29 Oct 2018
- Primary completion22 Feb 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomi Myrberg, Umeå University
- Investigators
- Tomi Myrberg, MD PhD, Principal investigator, Umea University, senior lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723109
- Sponsor's protocol ID
- 2016/361-31 IV
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management and Safety Aspects During Target Controlled Infusion (TCI) Compared to Rapid Sequence Induction (RSI) of Anesthesia in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03723109
- Acronym / sponsor ID
- 2016/361-31 IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Oct 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.
The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.
Detailed description
The aims of this study are to evaluate and compare feasibility of airway management and risk for desaturation during standardized target controlled infusion (TCI) and rapid sequence induction (RSI) of anesthesia. A conventional way to induce anesthesia, i.e. manual injection of anesthetics, may be more accurate and predictable compared to dosing regimes based on complex mathematical algorithms used in TCI-systems. In addition, today many different models are presented and there is no consensus which kind of TCI-algorithm should be used universally. Moreover, dosing algorithms are most complex and challenging in underweight and morbid obesity. There are many publications on this field, but no data of feasibility of airway management can be found. Indeed, RSI induction is traditionally blamed to be risky and not recommended as a first choice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cohort, electively scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) and minor general abdominal surgery.
Key inclusion criteria (4 listed)
- signed informed consent
- BMI < 35 kg/m2
- preoperative assessment accepted by consultant anesthesiologist
- scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) or minor general abdominal surgery.
Key exclusion criteria (8 listed)
- not signed consent
- instable angina pectoris
- severe bronchial asthma
- severe chronic obstructive pulmonary disease
- dementia
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 |
|---|---|---|
| Induction of anesthesiaAlso: Anesthesia inductionStandardized TCI and RSI anesthesia induction | Procedure or surgery | – |
Primary outcome
Safety time for apnea
Time frame: 10min
measurement of length of period for apnea during TCI and RSI induction by a timer
1 secondary outcome
Duration of spontaneous breathing
Time frame: 10min
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 26 Sep 2019.
- 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.
Tomi Myrberg, MD PhD principal investigator
Umea University, senior lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effect and Anesthesia, run by Umeå University at 1 site in Sweden.
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 8 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 26 Sep 2019. 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 Sweden. 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?
Safety time for apnea (time frame: 10min). 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 26 Sep 2019.