Effects of Two Different Eye Care Practices on Eye Complications in Mechanically Ventilated Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Conjunctival Edema in Critically Ill Patients
研究概览
简要总结
This study was designed as a prospective, randomized controlled experimental study aiming to compare different approaches to eye care in intensive care patients receiving mechanical ventilation. In this study, patients receiving mechanical ventilation in the intensive care unit will be randomly assigned to four groups using a simple randomization method:
- Control Group: Standard Eye Care
- Intervention Group 1: Eye Care with Eye Care Kit
- Intervention Group 2: Eye Care According to Eye Care Protocol
- Intervention Group 3: Eye Care with Both Protocol and Eye Care Kit Research Hypotheses H1: Eye care provided using a care protocol is more effective in preventing the development of complications compared to standard eye care.
H2: Eye care provided using an eye care kit is more effective in preventing the development of ocular complications compared to standard eye care.
H3: The combined use of an eye care kit and a care protocol is more effective in preventing the development of ocular complications compared to using the care protocol alone.
H4: The use of an eye care kit is more effective in preventing the development of ocular complications compared to the use of a care protocol.
详细描述
Study Design and Methodology
In this study, patients receiving mechanical ventilation support in the intensive care unit will be randomly assigned to four groups using a simple randomization method:
- Control Group: Standard Eye Care Group There is no established protocol or guideline for eye care in the intensive care unit where the study will be conducted. Routine eye care involves the use of sterile gauze and sterile saline. During routine suctioning procedures, patients' eyes are not closed. If a patient is unable to achieve full eyelid closure, their eyes are covered with an eye patch or sterile gauze.
- Intervention Group 1: Eye Care Using an Eye Care Kit Eye care will be performed using an eye care kit. All nursing staff in the intensive care unit will receive training regarding the contents and usage of the kit. Patients in this group will receive eye care solely using the kit, following a 4-times-daily care protocol. For patients with lagophthalmos, eyes will be covered using the eye closure pad provided in the kit.
- Intervention Group 2: Eye Care According to an Eye Care Protocol
- All ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving care under the protocol.
- Patients' ocular risk factors will be assessed daily, followed by eye care based on the protocol.
- Changes in ocular condition will be assessed and documented, and ICU physicians will be informed as necessary.
- In cases of incomplete eyelid closure, eyes will be covered upon physician notification.
- Patients will be assessed daily for signs of eye infection and conjunctival edema in accordance with the protocol. If signs of infection or complications occur during the day, they will be marked with a (+) symbol on the form.
- Intervention Group 3: Eye Care Using Both the Eye Care Protocol and the Eye Care Kit
- ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving this combined care.
- Eye care will be performed using the Eye Care Kit developed by the researchers in accordance with the protocol.
- Patients will be assessed for ocular risk factors daily, and eye care will be provided according to the management guidelines of the protocol, including:
- In cases of incomplete eyelid closure, the eyes will be covered with physician knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Receiving mechanical ventilation
- •Glasgow Coma Scale (GCS) score < 12
- •At least 24 hours have passed since ICU admission
- •Baseline Schirmer test result indicating tear production > 5 mm prior to study inclusion
排除标准
- •Diagnosed with brain death
- •Presence of facial or ocular trauma
- •Patients with head trauma
- •Patients who have undergone brain surgery
- •Patients diagnosed with an eye infection or chemosis
- •Withdrawal Criteria:
- •Patient's death during the study period
- •Extubation of the patient before completion of the care period
研究组 & 干预措施
Control Group: Standard Eye Care Group
There is no established protocol or guideline for eye care in the intensive care unit where the study will be conducted. Routine eye care involves the use of sterile gauze and sterile saline. During routine suctioning procedures, patients' eyes are not closed. If a patient is unable to achieve full eyelid closure, their eyes are covered with an eye patch or sterile gauze. The Schirmer test will be administered to both eyes on the first day (prior to the first eye care intervention), as well as on the fifth, seventh, and tenth days after eye care is performed. Signs and symptoms of eye infection and chemosis will be evaluated daily after the second eye care procedure. Data for this group will be collected, and the administration and documentation of eye care will be monitored.
干预措施: Control Group: Standard Eye Care Group (Other)
Intervention Group 1: Eye Care Using an Eye Care Kit
Eye care will be performed using an eye care kit. All nursing staff in the intensive care unit will receive training regarding the contents and usage of the kit. Patients in this group will receive eye care solely using the kit, following a 4-times-daily care protocol. For patients with lagophthalmos, eyes will be covered using the eye closure pad provided in the kit. The Schirmer test will be performed on both eyes on the first day prior to the initial eye care intervention, and on the fifth, seventh, and tenth days following eye care, with results recorded. Signs of infection and chemosis will be assessed daily after the second eye care session. Data collection will be done using , and eye care administration will be tracked.
干预措施: Intervention Group 1: Eye Care Using an Eye Care Kit (Other)
Intervention Group 2: Eye Care According to an Eye Care Protocol
All ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving care under the protocol.
Patients' ocular risk factors will be assessed daily, followed by eye care based on the protocol.
Changes in ocular condition will be assessed and documented, and ICU physicians will be informed as necessary.
In cases of incomplete eyelid closure, eyes will be covered upon physician notification.
Patients will be assessed daily for signs of eye infection and conjunctival edema in accordance with the protocol. If signs of infection or complications occur during the day, they will be marked with a (+) symbol on the form.
The Schirmer test will be applied on the first day (prior to the initial eye care session) and after eye care on days 5, 7, and 10, with results documented.
干预措施: Intervention Group 2: Eye Care According to an Eye Care Protocol (Other)
Intervention Group 3: Eye Care Using Both the Eye Care Protocol and the Eye Care Kit
ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving this combined care.
Eye care will be performed using the Eye Care Kit developed by the researchers in accordance with the protocol.
Patients will be assessed for ocular risk factors daily, and eye care will be provided according to the management guidelines of the protocol.
In cases of incomplete eyelid closure, the eyes will be covered with physician knowledge.
Patients will be assessed daily for signs of infection and conjunctival edema as per the protocol. Any signs of infection or complications will be marked with a (+) on the form.
The Schirmer test will be performed on both eyes before the first eye care session on day 1, and following eye care on days 5, 7, and 10, with results recorded.
干预措施: Intervention Group 3: Eye Care Using Both the Eye Care Protocol and the Eye Care Kit (Other)
结局指标
主要结局
Conjunctival Edema in Critically Ill Patients
时间窗: Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Conjunctival Edema (Chemosis): Chemosis is the edema of the conjunctiva, which is a thin, transparent membrane covering the inner surface of the eyelids and the white part of the eyes (sclera). It refers to the swelling of this membrane that lines the ocular surface.
Ocular Infections in Critically Ill Patients
时间窗: Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Signs and Symptoms of Ocular Infection: Redness, ocular discharge, crusting along the eyelid margins, adhesion of eyelashes (eyelashes sticking together), corneal discoloration (loss of corneal transparency), periorbital edema.
Dry Eye in Critically Ill Patients
时间窗: Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Dry Eye: Dry eye is a multifactorial disease of the ocular surface, defined by tear film instability and associated with symptoms including ocular discomfort, burning sensation, irritation, dryness, visual blurring, and foreign body sensation."
次要结局
未报告次要终点
研究者
Yildiz Deniz
PhD Student
Istanbul Saglik Bilimleri University