Improving Sleep Quality in Flap Patients in the SICU

NCT03957317 | Completed

• 1 other identifier: STU082017-007
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Keywords

Surgery; Postoperative sleep deprivation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores

  2 days from ICU admission

• Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores

  2 days from ICU admission

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Eye mask and ear plugs OTHER

Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 33870919 DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Bryan T Romito, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: February 6, 2018
• Primary Completion: October 5, 2019
• Study Completion: October 5, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)