Airway Management During TCI vs RSI Anesthesia Induction

September 25, 2019 updated by: Tomi Myrberg, Umeå University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Luleå, Sweden, 97180
        • Sunderby teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive cohort, electively scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) and minor general abdominal surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety time for apnea
Time Frame: 10min
measurement of length of period for apnea during TCI and RSI induction by a timer
10min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of spontaneous breathing
Time Frame: 10min
measurement of duration of spontaneous breathing during TCI and RSI induction by a timer
10min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Tomi Myrberg, MD PhD, Umea University, senior lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

October 25, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/361-31 IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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