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Clinical Trials/CTRI/2024/04/066532
CTRI/2024/04/066532
Recruiting
Phase 2

Efficacy of Communication APP (C-APP) on ease of communication and patient satisfaction among patients with mechanical ventilation in ICUs at a tertiary care center - A Randomized Controlled Trial

Not provided1 site in 1 country140 target enrollmentStarted: May 15, 2024Last updated:

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
140
Locations
1
Primary Endpoint
1.Ease of Communication

Overview

Brief Summary

The Efficacy of Communication APP on ease of communication and patient satisfaction among patients with mechanical ventilation in Intensive care units at a tertiary care center is being investigated through a Randomized Controlled Trial

The objective of this trial is to assess the efficacy of Communication APP in improving ease of communication and patient satisfaction among ICU patients undergoing mechanical ventilation

Patients will be  randomized into experimental and control groups with the experimental group receiving Communication APP alongside routine aids while the control group receives routine aids only

Data collection involves screening patients based on various scales such as the Glasgow Coma Scale and Richmond Agitation Sedation Scale

Baseline assessment includes evaluating ease of communication and physiological parameters like heart rate and blood pressure

During the intervention period a minimum of 10 communication exchanges are facilitated using Communication APP or routine aids

Post-test evaluation occurs 2 to 48 hours post extubation or tracheostomy that includes assessing ease of communication and patient satisfaction

Continuous physiological monitoring of vital signs is conducted before then during and after each communication exchange

Primary outcomes focus on communication ease and patient satisfaction with secondary outcomes examining physiological responses

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients of age above 18 years.
  • Both male and female patients Patients who are alert, conscious, stable, and attempting to communicate.
  • Patients on mechanical ventilator (day 3 to 2 weeks) Patients who are willing to participate Patients who can read/write/understand English/Tamil.

Exclusion Criteria

  • Patients with dementia, delirium, psychiatric disorders Patients who have difficulty to understand and follow instructions.
  • Patients whose condition is hemodynamically unstable Patients with severe hearing, visual which cannot be corrected with aids.
  • Patients with preexisting communication impairment such as conditions affecting speech articulation, language comprehension, or expression, including aphasia, dysarthria, or language disorders.
  • Patients on paralytic drugs.
  • Patients on CMV(Continuous Mandatory Ventilation) Mode.

Outcomes

Primary Outcomes

1.Ease of Communication

Time Frame: 1.Ease of communication | Baseline/Pretest:Assessment will be conducted on day 3 of mechanical ventilation after randomization. | Post test: Assessments will be conducted daily from day 4 upto day 10 of mechanical ventilation according to duration of ventilation,example patient on ventilation for 10 days post test will be done on day 4, day 5, day 6, day 7, day 8, day 9, and day 10. | 2. Patient Satisfaction (Post test only)This assessment will be done on day 1 or 2 after extubation/tracheostomy.

2.Patient satisfaction about Communication Aid

Time Frame: 1.Ease of communication | Baseline/Pretest:Assessment will be conducted on day 3 of mechanical ventilation after randomization. | Post test: Assessments will be conducted daily from day 4 upto day 10 of mechanical ventilation according to duration of ventilation,example patient on ventilation for 10 days post test will be done on day 4, day 5, day 6, day 7, day 8, day 9, and day 10. | 2. Patient Satisfaction (Post test only)This assessment will be done on day 1 or 2 after extubation/tracheostomy.

Secondary Outcomes

  • 1.Physiological Parameters(Heart rate,Blood Pressure,Respiratory Rate,ECG and Oxygen Saturation)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

ANNAPOORANI M

SRM College of Nursing,Faculty of Medical & Health Sciences ,SRMIST.

Study Sites (1)

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