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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04053556
Other study ID # 2489
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2019
Est. completion date August 8, 2019

Study information

Verified date August 2019
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.


Description:

The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.

A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.

Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).

Results were presented as means of standardized scores (z score) with their interquartile range (IQR).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 8, 2019
Est. primary completion date August 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Internal Medicine residents on the second or third year of formation.

Exclusion Criteria:

- Denial to participate in the study or to the informed consent.

Study Design


Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires, Peron 4190 Ciudad Autonoma de Buenos Aires Capital Federal

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurological evaluation using Paced Auditory Serial Addition Test (PASAT) Post on-call cognition assessment Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Primary Burn Out Maslach questionaire filled by participant through study completion, an average of one year
Primary Conners Continuous Performance Test 2 (CPT) Post on-call attention test Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Primary Rey auditory verbal learning test (RAVLT) Post on-call cognition assessment Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Primary F-A-S test Post on-call verbal fluency Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Primary Direct and indirect digit span Post on-call short-term verbal memory Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Secondary Depression Questionaire filled by participant through study completion, an average of one year
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