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CTRI Number  CTRI/2016/08/007134 [Registered on: 02/08/2016] Trial Registered Prospectively
Last Modified On: 18/07/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Critical Care]  
Study Design  Other 
Public Title of Study   Incidence and risk factors Associated with eye complications in ICU Patients on ventilator and effect of special eye care strategy 
Scientific Title of Study   Incidence and Risk Factors Associated with Ocular Surface Disorders in Ventilated ICU Patients and Impact of Protocolised Eye Care 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila Nainan Myatra 
Designation  Professor,Deptt.of Anaesthesiology ,Critical Care and Pain,TMH,Mumbai 
Affiliation  Tata Memorial Hospital,Mumbai 
Address  Deptt of Anaesthesiology ,Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Bhagat 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  Deptt of Anaesthesiology ,Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9560769742  
Fax    
Email  drvikasbhagat@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikas Bhagat 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  Deptt of Anaesthesiology ,Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9560769742  
Fax    
Email  drvikasbhagat@yahoo.com  
 
Source of Monetary or Material Support  
Deptt. of Anaesthesiology,Critical Care & Pain, Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila Nainan Myatra  Surgical and Medical ICU, Department of Anesthesi,Critical Care and Pain,Tata Memorial Hospital  Tata Memorial Hospital, Dr Ernest Borges Road, Parel,Mumbai-400012
Mumbai
MAHARASHTRA 		 9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I, Tata Memorial Hospital,Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All adult ( age more than 18 years ) patients in ICU who are ventilated,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Protocolized Eye Care and Hydroxy Propyl Methyl Cellulose Eye Ointment   Eye lubricating Ointment applied four hourly in both eyes 
Comparator Agent  routine eye care with Hydroxy Propyl Methyl Cellulose eye drops  Artificial tears/Lubricating eye drops- one drop in each eye applied two hourly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult (age more than 18 years ) patients in ICU who are ventilated. 
 
ExclusionCriteria 
Details  1.Pt who has facial or eye injury
2.Pts which present with ocular surface abnormalities
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of ICU Acquired Risk Factors with the incidence of Ocular Surface Disorders in ventilaled patients  6 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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 :

1. If conjunctiva swollen ( Chemosis )

2. Red eye

3. 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 )

 
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