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Improving Sleep Quality in Flap Patients in the SICU

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eye mask and ear plugs
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation focused on measuring Surgery, Postoperative sleep deprivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 17, 2019
Last Updated
October 10, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03957317
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Surgery, Postoperative sleep deprivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eye mask and ear plugs
Intervention Description
Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.
Primary Outcome Measure Information:
Title
Improvement in Richards-Campbell Sleep Questionnaire (RCSQ) scores
Description
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.
Time Frame
2 days from ICU admission
Secondary Outcome Measure Information:
Title
Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores
Description
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.
Time Frame
2 days from ICU admission
Title
Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores
Description
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.
Time Frame
2 days from ICU admission

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan T Romito, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only deidentified aggregate data can be shared with other researchers at this time.
Citations:
PubMed Identifier
33870919
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.
Results Reference
derived

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Improving Sleep Quality in Flap Patients in the SICU

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