Airway Management During TCI vs RSI Anesthesia Induction

• Sponsor: Umeå University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03723109
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 10

Study Details

Study Description

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	Phase
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

• 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: Oct 29, 2018
• Actual Primary Completion Date: Feb 22, 2019
• Actual Study Completion Date: May 31, 2019

Outcome Measures

Primary Outcome Measures

1. Safety time for apnea [10min]

   measurement of length of period for apnea during TCI and RSI induction by a timer

Secondary Outcome Measures

1. Duration of spontaneous breathing [10min]

   measurement of duration of spontaneous breathing during TCI and RSI induction by a timer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sunderby teaching hospital	Luleå		Sweden	97180

Sponsors and Collaborators

• Umeå University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tomi Myrberg, Senior lecturer, MD PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT03723109
• Other Study ID Numbers: 2016/361-31 IV
• First Posted: Oct 29, 2018
• Last Update Posted: Sep 26, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Sep 26, 2019