Impact of Sleep Quality on Outcomes After Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Complications, Postoperative; Sleep; Atrial Fibrillation; Delirium, Postoperative
• Interventions: Device: Eye masks and ear plugs

• Registration Number: NCT06527105
• Lead Sponsor: Amrita Institute of Medical Sciences & Research Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-22
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Eye masks and ear plugs	Eye masks and Ear plugs given during sleep

Primary Outcome Measures

Name	Time	Method
Quality of sleep	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation	6 months	Postoperative atrial fibrillation
Vasoactive inotropic score	6 months	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
Mechanical ventilation	6 months	Duration of mechanical ventilation (hours)
Delirium	6 months	Postoperative Delirium
Intensive care unit stay	6 months	Duration of intensive care unit stay (in hours to days)

Trial Locations

Locations (1)

Dr. Nagarjuna; 🇮🇳 Kochi, Kerala, India