Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Airway Management During TCI vs RSI Anesthesia Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723109
Recruitment Status : Completed
First Posted : October 29, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tomi Myrberg, Umeå University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.

Condition or disease Intervention/treatment
Adverse Effect Anesthesia Airway Complication of Anesthesia Procedure: Induction of anesthesia

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airway Management and Safety Aspects During Target Controlled Infusion (TCI) Compared to Rapid Sequence Induction (RSI) of Anesthesia in Non-cardiac Surgery
Actual Study Start Date : October 29, 2018
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : May 31, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: Induction of anesthesia
    Standardized TCI and RSI anesthesia induction
    Other Name: Anesthesia induction

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety time for apnea [ Time Frame: 10min ]
    measurement of length of period for apnea during TCI and RSI induction by a timer


Secondary Outcome Measures :
  1. Duration of spontaneous breathing [ Time Frame: 10min ]
    measurement of duration of spontaneous breathing during TCI and RSI induction by a timer


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive cohort, electively scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) and minor general abdominal surgery.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723109


Locations
Layout table for location information
Sweden
Sunderby teaching hospital
Luleå, Sweden, 97180
Sponsors and Collaborators
Umeå University
Investigators
Layout table for investigator information
Principal Investigator: Tomi Myrberg, MD PhD Umea University, senior lecturer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tomi Myrberg, Senior lecturer, MD PhD, Umeå University
ClinicalTrials.gov Identifier: NCT03723109    
Other Study ID Numbers: 2016/361-31 IV
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs