Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery

NCT04786899 | Completed

• 1 other identifier: 20200942
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

Conditions

Delirium in Old Age; Sleep Disturbance; Circadian Rhythm Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery

  Delirium will be assessed using the Confusion Assessment Method.

  Up to 7 days post surgery.

Secondary Outcomes (6)

• Percentage of participants with preoperative sleep disturbance

  Up to 7 days before surgery

• Pittsburgh Sleep Quality Index (PSQI) score

  baseline

• Insomnia Severity Index (ISI) score

  baseline

• Epsworth Sleepiness scale (ESS) score

  baseline

• STOP-BANG Score

  baseline

Study Arms (1)

Hispanic/Latino patients undergoing cardiothoracic surgery

Observational study of patients scheduled for cardiothoracic surgery as part of standard of care. Patients will be followed up to 30 days prior to surgery and up to 7 days after surgery or hospital discharge, whichever is sooner. Patients preoperative sleep patterns and postoperative delirium will be followed.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hispanic/Latino patients scheduled for cardiothoracic surgery at the University of Miami.

You may qualify if:

• Self identify as Hispanic/Latino or preferred language as Spanish
• Undergoing scheduled elective and urgent cardiothoracic surgery
• years of age and older

You may not qualify if:

• Inability to consent
• preferred language other than English, Spanish or Portuguese
• emergency surgery
• anticipated discharge \< 48 hours
• Individuals \< 50 years of age
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Parasomnias; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Dyssomnias; Occupational Diseases

Study Officials

• Elizabeth Mahanna Gabrielli, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: February 12, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)