Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.
Phase: NA
Conditions: Acute Coronary Syndromes, Ticagrelor, Dyspnea
Sponsor: Acibadem University

Cover Page 
 
Official Title: Effect of Fan Therapy on Dyspnea Associated With Ticagrelor Administration 
in Intensive Care Patients 
NCT Number: Not yet assigned 
Document Date: 18 July 2024 
Prepared by: Emine Tuğba Yorulmaz, PhD Student 
Supervised by: Asst. Prof. Arzu Erkoç 
Document Type: Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
1. Study Objectives 
Primary Objective: To determine the effect of fan therapy on ticagrelor-associated dyspnea in 
intensive care patients. 
Secondary Objectives: To assess the incidence, severity, and number of dyspnea episodes 
following ticagrelor administration with or without fan therapy. 
 
2. Study Design 
Interventional, randomized, parallel assignment. 
Two arms: Control (Standard Care) and Experimental (Standard Care + Fan Therapy). 
Masking: Single (Outcomes Assessor). 
Enrollment: 110 participants (55 per group). 
Study Duration: Approximately 2 days per patient. 
 
3. Interventions 
Arm 
Intervention 
Description 
Experimental Standard Care + Fan Therapy 
Standard care plus hand fanning for 5 
minutes at 30, 60, 120 minutes after ticagrelor administration. Fan directed toward patient’s 
face from ~15 cm. Dyspnea severity and number of episodes recorded. Device: Hand Fan. 
Control 
Standard Care 
Routine ward care including semi-Fowler position and 
breathing exercises. Presence, number, and severity of dyspnea attacks recorded during first 
2 hours after ticagrelor administration. 
 
4. Outcome Measures 
Incidence of Dyspnea 
Description: Number of patients experiencing dyspnea within 2 hours after ticagrelor 
administration. 
Time Frame: T1=Baseline, T2=30 min, T3=60 min, T4=120 min 
Unit of Measure: Number of patients 
 
Severity of Dyspnea 
Description: Dyspnea severity measured using the Modified Borg Dyspnea Scale (0–10). 
Time Frame: Same as above 
Unit of Measure: Score (0–10) 

 
Number of Dyspnea Episodes 
Description: Total number of dyspnea episodes per patient during the first 2 hours. 
Time Frame: Same as above 
Unit of Measure: Count 
 
5. Randomization 
Participants randomized using randomizer.org; Set 1=Control, Set 2=Experimental. 
 
6. Statistical Analysis Plan 
 
Sample size calculated for 2 conjugate groups (α=0.05, β=0.20, power=0.80, effect 
size=0.10). 
Minimum n=100, adjusted to 110 to account for data loss. 
Analysis performed by a statistician not involved in data collection.