Improving Sleep Quality in Flap Patients in the SICU

NCT ID: NCT03957317

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2019-10-05

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.

Conditions

Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Eye mask and ear plugs

Intervention Type: OTHER

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

Interventions

Eye mask and ear plugs

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bryan Romito

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan T Romito, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33870919 (View on PubMed)

Other Identifiers

STU082017-007

Identifier Type: -

Identifier Source: org_study_id