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Not yet recruiting NCT07397221

Oropharyngeal Humidification After Extubation on Thirst

No phase Interventional Coronary Artery Bypass

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: Oropharyngeal Humidification with Water Spray.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass. 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

The Effect of Oropharyngeal Humidification After Extubation on Thirst, Pain, and Anxiety in Patients Undergoing Coronary Artery Bypass Surgery: A Randomized Controlled Study

Overview

In patients who have undergone endotracheal intubation following cardiac surgery, symptoms such as thirst, dysphagia (difficulty swallowing), restlessness, nausea, and vomiting are frequently observed, and these conditions negatively affect the patients' overall comfort. Especially in the post-intubation period, dryness in the mouth and throat, an intense feeling of thirst, and difficulty swallowing can lead to feelings of suffocation, helplessness, fear, and anxiety in patients. Effective management of these symptoms is critically important both for accelerating the recovery process and for increasing patient satisfaction. Traditionally, methods such as moistening the mouth with a cotton swab have been used to relieve complaints like thirst and dry mouth. However, these practices are often insufficient and have limited effectiveness in increasing patients' comfort. In recent years, the use of oropharyngeal sprays has emerged as an innovative and effective approach to alleviate symptoms such as thirst and dry mouth. In a randomized controlled trial conduct, it was shown that a spray-based oropharyngeal moisturizing program significantly reduced the severity of thirst and discomfort in patients who underwent intubation after cardiac surgery. Thirst and discomfort scores were found to be significantly lower in the spray-applied groups compared to the control group, and no significant difference was observed between the groups in terms of dysphagia frequency or adverse events. Similarly, studies conducted in different surgical and intensive care populations have shown that applications of cold water or cold saline sprays significantly reduce complaints of thirst and dry mouth, increase patient comfort, and are safe to use. Additionally, it has been reported that alternative approaches such as menthol lozenges or aromatherapy also have positive effects on thirst, nausea, and comfort after cardiac surgery. Examining the effects of oropharyngeal sprays and similar practices on parameters such as thirst, dysphagia, discomfort, nausea, vomiting, and overall comfort in patients who are intubated after cardiac surgery may contribute to the development of innovative and effective approaches in patient care. Integrating such practices into postoperative care protocols carries significant potential for increasing patient comfort and supporting the recovery process. This randomized controlled study aims to investigate the effects of oropharyngeal humidification after extubation on thirst, pain, and anxiety in patients undergoing coronary artery bypass surgery.

Interventions

  • Other Oropharyngeal Humidification with Water Spray
    Room-temperature drinking water is administered as an oral spray to multiple areas of the oral cavity (upper jaw, lower jaw, left and right cheek, and tongue). The researcher applies the spray twice per hour for 4 hours after extubation in patients undergoing coronary artery bypass surgery.

Primary outcome measures

  • Thirst Severity [Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention]
Secondary outcome measures (4)
  • Thirst-Related Discomfort [Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention]
  • Pain Severity [Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention]
  • Anxiety Level [Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention]
  • Post-Extubation Complications [Time frame: Continuous monitoring during the 4-hour intervention period]

Eligibility criteria

Inclusion criteria

  • Age 18-65
  • Undergoing coronary artery bypass surgery
  • Postoperative mechanical ventilation and extubation
  • Able to provide informed consent

Exclusion criteria

  • Neuromuscular diseases (e.g., stroke, Parkinson's disease)
  • Head/neck deformities
  • Pre-existing dysphagia
  • Tracheostomy
  • Inability to participate in assessments

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Sancaktepe Şehit Prof. Dr. İlhan Varank Eğitim ve Araştırma Hastanesi — Istanbul

Publications

  • References Lin, R., Chen, H., Chen, L., Lin, X., He, J., & Li, H. (2022). Effects of a spray-based oropharyngeal moisturising programme for patients following endotracheal extubation after cardiac surgery: A randomised, controlled three-arm trial.. International journal of nursing studies, 130, 104214. https://doi.org/10.1016/j.ijnurstu.2022.104214 Gungor, S., Tosun, B., Candir, G., & Ozen, N. (20

Identifiers

NCT: NCT07397221 · 218984

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗