Clinical trial NCT03957317: Improving Sleep Quality in Flap Patients in the SICU
Official title: Improving Sleep Quality and Satisfaction for Postoperative Plastic Surgery Flap Patients in the CUH SICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: Surgery
Postoperative sleep deprivation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study comparing effects of wearing eye masks and ear plugs for sensory deprivation against the standard-of-care (no treatment). Primary outcome is measuring difference between RCSQ scores (sleep quality survey).
Primary purpose: TREATMENT

Brief summary: This investigation will be a randomized interventional prospective quality improvement study. Patients undergoing plastic surgery with flap procedures (n =123) will be randomized to evaluate the effect of the implementation bundle for sleep quality improvement in the surgical intensive care unit (SICU). Roughly one half of the patients (n =62) will be randomized to the intervention group. This group will receive the intervention bundle which consists of providing ear plugs and eye masks to patients and their family members. Roughly one half of the patients (n =62) will be randomized to the control group. This group will receive "usual care", which does not include ear plugs or eye masks and lacks specified times for laboratory draws and imaging studies. For each of the two groups, the investigators will collect Richards-Campbell Sleep Questionnaire (RCSQ) scores, Confusion Assessment Method for the ICU (CAM-ICU) scores, and modified Family Satisfaction in the Intensive Care Unit (FS-ICU) scores. The investigators will administer the RCSQ to these patients following every night they spend in the SICU and the FS-ICU questionnaire immediately prior to their discharge from the ICU.

Detailed description: Patients will be identified during their presurgical clinic visit or anesthesia preoperative clinic visit for eligibility. The electronic medical record (Epic) will also be used for prescreening of potential study participants by reviewing the clinic visit daily schedule or operating room schedule. Then patient charts will be reviewed for initial data collection to determine the eligibility of potential subjects with the use of a HIPAA waiver form.

A discussion of risks, benefits, and alternatives will be performed. Following the discussion, informed written consent for clinical care and participation in the study will be obtained.

Roughly one half of the patients (n =62) will be randomized to the intervention group. This group will receive the intervention bundle which consists of providing ear plugs and eye masks to patients and their family members. Roughly one half of the patients (n =62) will be randomized to the control group. This group will receive "usual care", which does not include ear plugs or eye masks and lacks specified times for laboratory draws and imaging studies. For each of the two groups, the investigators will collect RCSQ scores, CAM-ICU scores, and modified FS-ICU scores. The investigators will administer the RCSQ to these patients following every night they spend in the SICU and the modified FS-ICU questionnaire immediately prior to their discharge from the ICU. The RCSQ is a short, 5-question, validated survey instrument for measuring sleep quality in ICU patients. The FS-ICU is a short, validated survey instrument for measuring family satisfaction with care and decision making in the ICU. The modified version is more focused on satisfaction of the patient rather than their family member(s). The CAM-ICU is a validated screening test for delirium, and scores are currently charted in the electronic medical record (EMR) as a part of routine monitoring in the SICU. The anticipated length of time for the project is 28 weeks.

Eligibility criteria: Inclusion Criteria:

* Adult patients age ≥ 18 years
* Individuals undergoing plastic surgery flap procedures requiring hourly monitoring

Exclusion Criteria:

* Pregnancy
* Incarceration
* Diagnosis of obstructive sleep apnea
* Diagnosis of insomnia or other sleep disturbance

Primary outcomes:
measure: Improvement in Richards-Campbell Sleep Questionnaire (RCSQ) scores
timeFrame: 2 days from ICU admission
Secondary outcomes:
measure: Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores
timeFrame: 2 days from ICU admission
measure: Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores
timeFrame: 2 days from ICU admission
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Bryan T Romito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obanor OO, McBroom MM, Elia JM, Ahmed F, Sasaki JD, Murphy KM, Chalk S, Menard GA, Pratt NV, Venkatachalam AM, Romito BT. The Impact of Earplugs and Eye Masks on Sleep Quality in Surgical ICU Patients at Risk for Frequent Awakenings. Crit Care Med. 2021 Sep 1;49(9):e822-e832. doi: 10.1097/CCM.0000000000005031.