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CTRI Number  CTRI/2024/10/075412 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of communication board among intubated patients 
Scientific Title of Study   Effectiveness of low Tech Augmentative and Alternative Communication (AAC) on ease of communication among patients with Endotracheal tube admitted in critical care units of tertiary care hospital, Mangaluru. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Merlyn Priya Moras 
Designation  Post Graduate Student (Nursing) 
Affiliation  Father Muller College of Nursing 
Address  Medical Surgical Nursing, 1st M.Sc Nursing,Father Muller College of Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9535857530  
Fax    
Email  morasmerlyn88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ashwin Bromeo J 
Designation  Associate Professor 
Affiliation  Father Muller College of Nursing 
Address  Department of Medical Surgical Nursing, Father Muller College of Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9686923121  
Fax    
Email  bromeoj@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Mrs Jubee Joseph 
Designation  Assistant Professor 
Affiliation  Father Muller College of Nursing 
Address  Department of Medical Surgical Nursing, Father Muller College of Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8722831688  
Fax    
Email  jubeejoseph@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller College of Nursing, Kankanady -575002 
 
Primary Sponsor  
Name  Mrs Merlyn Priya Moras 
Address  Father Muller College of Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575 002 
Type of Sponsor  Other [Self] 
 
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 
Mr Ashwin Bromeo J  Father Muller Medical College Hospital  critical care units, kankanady, mangaluru
Dakshina Kannada
KARNATAKA 		 9686923121

bromeoj@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z991||Dependence on respirator,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  low Tech Augmentative and Alternative Communication (AAC)  low Tech AAC, a communication tool consisting of pictures and words in different regional languages put up in a spiral will be used, in helping the patients to point out their needs which they intend to communicate while on endotracheal tube for about 24-48 hours from the pre-test, 1 month total data collection will be done 
Comparator Agent  Standard routine communication  Patients in the control group will adhere to standard routine communication practices 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients who are admitted in critical care units for 24-48 hours with endotracheal tube
inserted orally
• Patients with ET tube having a score of 11 in a GCS
• Patients with ET tube having a score of 1, 2 in Richmond Agitation-Sedation Scale (RASS)
 
 
ExclusionCriteria 
Details  • Patients who can’t express their communication needs being in the state of ICU psychosis and having history of psychiatric illness.
• Patient who can’t cooperate with the study.
• Patients who are having sensory perceptual disorders, corneal ulcer, exposure keratitis, some degree of hearing inabilities and loss of vision.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There will be significant difference between mean pre and post-test scores of ease of communication among patients in the interventional group  24-48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "5"
Final Enrollment numbers achieved (India)="5" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   BACKGROUND: Many patients are kept on endo tracheal tube for the treatment and in post anesthesia room waiting for recovery. These are also conscious and oriented, wanted to communicate about their discomfort about the tube, pain in surgical site or Intra Venous catheter, wanted to be in comfortable position, anxious about the recovery etc. Researcher also found the care givers and the patients are failing to communicate effectively which creates more frustration. There are high Tech AAC and low Tech AAC available to solve this communication issues. Low Tech AAC involves a simple board with pictures and words mostly used in critical care units and what patients experiences while on ventilator.

AIM: The current study aims to assess the effectiveness of ow Tech Augmentative and Alternative Communication (AAC) on ease of communication among patients with Endotracheal tube admitted in critical care units.

MATERIAL AND METHODS: A Quasi-experimental research design will be used in the study. The target population consists of all oriented and conscious patients who are on endotracheal intubation with GCS score of 11 and Richmond Agitation-Sedation Scale (RASS) score of 1, 2 in the critical care units of tertiary care hospital, Mangaluru. The subjects will be selected based on the non-probability purposive sampling technique and calculated sample size 15/group. The informed consent will be obtained from the patients bystanders. The pre-test and post-test will be conducted by reading the questionnaire loudly and asking them to show the answers typed bold. Interventional group will be communicated through low Tech AAC and control group adhere to standard routine communication practices.
 
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