the Influence of Sleep Improvement Through Different Methods on Patients in ICU

NCT ID: NCT03480789

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-07-31

Brief Summary

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In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected.

Detailed Description

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In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected. The research aims to confirm that the sleep quality could have a great influence on patients in the ICU and different interventions would make various changes.

Conditions

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Metabolic Problems Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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eye patch

wearing the eye patch from 22:00 to 6:00 of the next day

Group Type EXPERIMENTAL

eye patch

Intervention Type DEVICE

wearing the eye patch from 22:00 to 6:00 of the next day

Dexmedetomidine

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

eye patch + DEX

given dexmedetomidine to meet RASS -1 and wearing the eye patch from 22:00 to 6:00 of the next day

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

eye patch

Intervention Type DEVICE

wearing the eye patch from 22:00 to 6:00 of the next day

usual treatment

treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexmedetomidine

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

Intervention Type DRUG

eye patch

wearing the eye patch from 22:00 to 6:00 of the next day

Intervention Type DEVICE

Other Intervention Names

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Precedex blinders

Eligibility Criteria

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Inclusion Criteria

* the postoperative patients that admission to icu is more than 48h

Exclusion Criteria

* pregnant or breastfeeding
* sleep disorders before operation
* poor liver or kidney function
* post craniocerebral operation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenkui Yu, Ph.D

Role: CONTACT

02568182222 ext. 60506

Facility Contacts

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Wenkui Yu

Role: primary

02568182222 ext. 60506

Other Identifiers

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sleep in ICU

Identifier Type: -

Identifier Source: org_study_id

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