Incidence and Risk Factors Associated with Ocular Surface Disorders in Ventilated ICU Patients and Impact of Protocolised Eye Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To identify the incidenceof Ocular Surface Disorder in sedated, ventilated patients in our ICU with the current eye care practices and the impact of a protocolised eye care on the incidence and outcome.
研究概览
简要总结
Methodology and Study Design
This study will be done in our 14 bed mixed medical surgical intensive care unit of Tata Memorial Hospital,Mumbai.All mechanically ventilated patients admitted in the ICU for more than 24 h will be included. This study will have prospective cohort design and it will be done as a before and after study.Total duration of the study will be 6 months in two different phases(each of three months).In the first phase Current Eye care practices will be continued for three months and the incidence of OSDs will be noted.In the second phase Protocolised Eye Care will be implemented after training the nurses ***(Nurses Education – Appendix I)***and incidence of OSDs will be noted. In both phases an Opthamologist( Dr Vikas Bhagat ) will examine the eye daily using standard criteria (Appendix II) and determine the incidence of OSD. Date related to demographic characteristics, comorbidities, APACHE II, reason of ICU admission, type of airway, duration of ventilation, type of feeding, sedation, use of muscle relaxant, sedation leveland the length of ICU stay /hospital stay will be recorded.
Phase 1
A. This will continue for three months and include observation of current ongoing practice of eye care in the medical intensive care unit.Three months of prospective data will be collected. The current practice is provided by the Nursing Staff and includes
1. Hand hygiene: Washing hand and wearing gloves
2. Cleaning eye with sterile normal saline soaked cotton balls
3. Application of lubricant eye drop (Moisol-Hydroxy Propyl Methyl Cellulose eye drop ) every 2 h ( e.g. 6 am,8am 10 am,12 pm,2 pm,4 pm,6 pm,8 pm, 10 pm,12 am, 2 am, 4 am)
4. Closure of eye lid manually if not completely close
5. In case of any redness, edema, or any other changes in normal examination of eyes-the staff Nurse informs the ICU Physician and Ophthalmologist opinion is asked for if needed.
B. All patients will be examined by an Ophthalmologist within 24 hours (baseline examination) of Invasive Ventilation and subsequently every 72 hourly( thrice a week )until the patient completes the study.
Phase 2 (Intervention Period)
A. This will start with the introduction of protocol made for eye care in the medical intensive care unit. Nurses will be trained in this protocol. Patients will be categorised on the basis of degree of conjunctival/corneal exposure . Current eye care practices will be continued and in addition to that few interventions ( as mentioned below )will be added according to the category of conjunctival/corneal exposure. Any abnormality in eyes that was observed by nursing staff was communicated to ICU physicians or whenever necessary ophthalmologists. Phase 2 will continued for 3 months.
B. All patients will be examined by an Ophthalmologist within 24 hours (baseline examination) of Invasive Ventilation and subsequently every 72 hourly( thrice a week )until the patient completes the study.
C. Patient categories
The patients will be categorised in the algorithm as follows:
1-Eyelids closed well
2-Pt with Lagophthalmos / Conjunctiva exposed / Cornea exposed / Prone ventilated.
D .Treatment policy :
Current eye care practices will be continued . Additional measures will be taken as mentioned below based on the degree of Conjunctival/corneal exposure.
Cat 1 - Eyelids closed well
Routine eye Care (current eye care practices) will be provided.
Cat2 - Pt with Lagophthalmos / conjunctiva exposed / cornea exposed / prone ventilated. (nurses will be trained to identify these condition)
1. Current eye care will be provided.
2. Eyes need lubricating with lacrilube Ointment ( HydroxyPropyl Methyl Cellulose Oint.) every 4 hours( e.g. 8 am,12 pm,4 pm, 8 pm, 12 am ) instead of Moisol eye drop.
E.Other Measures:
Nurse will alert on-duty ICU Resident in case they notices any of the following warning signs :
-
If conjunctiva swollen ( Chemosis )
-
Red eye
-
White line visible inside eye
F.Adjunctive measure: Measures taken during Oral suctioning:
1. Suctioning from the side of patients and not from the head end
2. Apply eye cover duringopen oropharyngeal suctioning for patients infection (especially Pseudomonas infection) and copious oral secretions.
3. Should not withdraw the suction catheter across patient’s face after suctioning
Study Completion Criteria:
1. Pt discharged from ICU or died
2. Pt has developed any ocular surface disorder
( As soon as any ocular surface disorder is noted Consultant Ophthalmogist opinion will be taken for further management of the patient )
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All adult (age more than 18 years ) patients in ICU who are ventilated.
排除标准
- •1.Pt who has facial or eye injury 2.Pts which present with ocular surface abnormalities.
结局指标
主要结局
To identify the incidenceof Ocular Surface Disorder in sedated, ventilated patients in our ICU with the current eye care practices and the impact of a protocolised eye care on the incidence and outcome.
时间窗: 6 months
次要结局
- Correlation of ICU Acquired Risk Factors with the incidence of Ocular Surface Disorders in ventilaled patients(6 months)
