NCT03723109

Brief Summary

The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

October 25, 2018

Last Update Submit

September 25, 2019

Conditions

Adverse EffectAnesthesiaAirway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Safety time for apnea

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

    10min

Secondary Outcomes (1)

  • Duration of spontaneous breathing

    10min

Interventions

Induction of anesthesiaPROCEDURE

Standardized TCI and RSI anesthesia induction

Also known as: Anesthesia induction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunderby teaching hospital

Luleå, 97180, Sweden

Location

Study Officials

  • Tomi Myrberg, MD PhD

    Umea University, senior lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer, MD PhD

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

October 29, 2018

Primary Completion

February 22, 2019

Study Completion

May 31, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)