Impact of Sleep Quality on Outcomes After Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmrita Institute of Medical Sciences & Research Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Not willing to give consent

Preoperative sleep medications use

Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eye masks and ear plugs

    Device

    Eye masks and ear plugs given during sleeping time in Icu After cardiac surgery

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Interventional groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

Atrial fibrillation

Postoperative atrial fibrillation

Time frame
6 months
2

Delirium

Postoperative Delirium

Time frame
6 months
3

Intensive care unit stay

Duration of intensive care unit stay (in hours to days)

Time frame
6 months
4

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

Time frame
6 months

Other outcomes

Sponsors and contacts

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