Improving Sleep Quality in Flap Patients in the SICU

Improving Sleep Quality and Satisfaction for Postoperative Plastic Surgery Flap Patients in the CUH SICU

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Other: Eye mask and ear plugs

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects in this group do not receive an eye mask or ear plugs, and receive standard of care (including pain control modalities). The subjects will receive a Richards-Campbell Sleep Questionnaire (RCSQ) survey for each night they spend in the Surgical ICU, as well as a modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey upon discharge from the ICU.
Experimental: Intervention; Subjects in this group receive an eye mask and ear plugs in addition to standard of care for pain control. The subjects will receive a Richards-Campbell Sleep Questionnaire (RCSQ) survey for each night they spend in the Surgical ICU, as well as a modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey upon discharge from the ICU.	Other: Eye mask and ear plugs; Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Richards-Campbell Sleep Questionnaire (RCSQ) scores	The Richards-Campbell Sleep Questionnaire (RCSQ) is a 5-item questionnaire used to evaluate perceived sleep depth, sleep latency, number of awakenings, efficiency, and sleep quality. Each RCSQ question is measured on a 0 (minimum) to 100 (maximum) visual-analogue scale, with higher scores representing better sleep. The primary outcome measure is a 25% increase in median RCSQ scores from the control group.	2 days from ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores	The Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire is a reliable and valid 34-item tool used to measure family satisfaction with care and decision-making in the ICU. Each question is completed using a 5-point Likert scale where 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor, and 6 = not applicable. A modified version of the FS-ICU survey used in the present study includes 14 questions and contains only questions directed toward the patient and not family members. Overall satisfaction score is calculated as the mean of the 14 items, with lower scores indicating greater satisfaction. A secondary outcome measure is to determine the difference in overall modified FS-ICU scores between control and intervention groups.	2 days from ICU admission
Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores	The Confusion Assessment Method for the ICU (CAM-ICU) is a valid and reliable delirium monitoring instrument for ICU patients. It tests for the presence of alteration in mental status, inattention, altered level of consciousness, and disorganized thinking. The presence of both altered mental status and inattention along with either altered consciousness or disorganized thinking corresponds to a positive CAM-ICU result, and delirium is present. If these criteria are not met, then CAM-ICU is considered negative, and delirium is absent. A secondary outcome measure is to determine the difference in positive CAM-ICU results between control and intervention groups.	2 days from ICU admission

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Bryan T Romito, MD, UT Southwestern Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): October 5, 2019

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Postoperative sleep deprivation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: STU082017-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only deidentified aggregate data can be shared with other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No