Impact of Sleep Quality on Outcomes After Cardiac Surgery

The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients

Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.

The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease

Study Overview

• Status: Recruiting
• Conditions: Sleep; Atrial Fibrillation; Delirium, Postoperative; Complications, Postoperative
• Intervention / Treatment: Device: Eye masks and ear plugs

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nagarjuna P, MD, DM; Phone Number: 091 9177208286; Email: drarjun83@gmail.com
• Study Contact Backup: Name: Nagarjuna P; Phone Number: 7981144584

Study Locations

• India
  • Kerala
    • Kochi, Kerala, India, 682041
      • Recruiting
      • Dr. Nagarjuna
      • Contact: Nagarjuna P, MD, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery

Exclusion Criteria:

• Not willing to give consent
• Preoperative sleep medications use
• Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional group; Eye masks and Ear plugs given during sleep	Device: Eye masks and ear plugs; Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery
No Intervention: Control group; Routine care given without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep	On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ). Each point in RCSQ will be scored using a visual analog score, ranging from 0-100. Total score will be calculated and then will be divided by 5.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Postoperative atrial fibrillation	6 months
Delirium	Postoperative Delirium	6 months
Intensive care unit stay	Duration of intensive care unit stay (in hours to days)	6 months
Vasoactive inotropic score	Vasoactive inotropic score is calculated by multiplying the dose of each vasoactive drug used with 10. (minimum score is 0, while maximum score can go upto 20. Higher the score worse is the outcome	6 months
Mechanical ventilation	Duration of mechanical ventilation (hours)	6 months

Collaborators and Investigators

• Sponsor: Amrita Institute of Medical Sciences & Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery; Sleep quality
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Postoperative Complications
• Other Study ID Numbers: IEC-AIMS-2023-CARDANES-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No