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Recruiting NCT07268859

Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea

No phase Interventional Acute Coronary Syndromes Ticagrelor Dyspnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STANDART CARE, STANDART CARE & FAN THERAPY.
Who it may be relevant to
Registry conditions: Acute Coronary Syndromes, Ticagrelor, Dyspnea. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.

Overview

This study will be conducted in the coronary intensive care unit of Dr. Siyami Ersek Chest, Heart and Vascular Surgery Training and Research Hospital. It aims to investigate the effect of hand fan therapy on ticagrelor-associated dyspnea in patients receiving ticagrelor.

Detailed description

Patients in the coronary intensive care unit receiving ticagrelor and meeting the inclusion criteria will be included. The study includes two groups: a control group receiving standard care and an experimental group receiving standard care plus hand fan therapy. A total of 110 participants (55 per group) will be recruited. Randomization will be performed using a computer-based randomization program. Due to the nature of the intervention and sample characteristics, participants and the researcher will not be blinded. Data will be analyzed by a statistician not involved in the study, and the findings will be reported.

Interventions

  • Other STANDART CARE
    Routine ward care including semi-Fowler position and breathing exercises. Standard institutional care will be applied. Presence, number, and severity of dyspnea attacks will be recorded during the first 2 hours after ticagrelor administration.
  • Other STANDART CARE & FAN THERAPY
    In addition to standard care, patients will undergo hand fanning for 5 minutes at 30, 60, and 120 minutes after ticagrelor administration. The fan will be directed toward the patient's face from a distance of \~15 cm. Dyspnea severity and number of episodes will be recorded during this period.

Primary outcome measures

  • Incidence of ticagrelor-associated dyspnea [Time frame: Time Frame: 0-120 minutes after ticagrelor administration (T1: baseline; T2: 30 min; T3: 60 min; T4: 120 min) Unit of Measure: Percentage of participants (%)]
Secondary outcome measures (1)
  • Time to onset of ticagrelor-associated dyspnea [Time frame: Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min)]

Eligibility criteria

Inclusion criteria

  • Between the ages of 18 and 65,
  • No severe hearing and vision problems,
  • Can speak and understand Turkish,
  • Easy to communicate with,
  • First-time sufferer of acute coronary syndrome (ACS) for the first time,
  • Decided to start ticagrelor therapy,
  • Able to adapt to treatment,
  • Individuals who volunteered to participate in the research.

Exclusion criteria

  • Having any problem that prevents you from communicating cognitively, emotionally and verbally,
  • Obstructive sleep abnormalities,
  • Have a disease that affects respiratory function (stage IV cancer, bronchial asthma, COVID-19, lung cancer, pulmonary edema, chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, pneumonia or bronchitis, etc.),
  • With metabolic abnormalities,
  • Intubated after the procedure,
  • Previously treated with ticagrelor,
  • Individuals who did not volunteer to participate in the study. Losses to follow up
  • Individuals who wish to leave the study voluntarily.
  • Saturation value below 95%,
  • The one with the arrest,
  • Who will not be able to fulfill the requirements of the work,
  • Individuals with life-threatening conditions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 2 centers
  • İstanbul Üniversitesi-Cerrahapaşa — Istanbul
  • Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştı — Istanbul

Identifiers

NCT: NCT07268859 · ATADEK2024-10/449 · Is an identifier other

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗