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Studying the effectiveness of Foley and Nelaton catheters on pain and mucosal damage during tracheostomy tube suctioning.

Comparative study of the effectiveness of Foley catheter and Nelaton on the amount of pain and mucosal Injury during tracheostomy tube suction in patients hospitalized in the intensive care units.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250828067031N1
Enrollment
90
Registered
2025-09-16
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Pain. Condition 2: mucosal injury. Acute pain due to trauma Other and unspecified injuries of lung

Interventions

Intervention 1: Intervention group: In this group, a Foley catheter with a maximum time of 10 to 15 seconds, a pressure of 100 to 120 mmHg in 12 sessions with a superficial depth and a maximum diamete

Sponsors

Zabol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Having a tracheostomy tube for more than 24 hours and less than 14 days. Ventilation with a ventilator and inability to communicate verbally (to prevent distortion of the pain assessment score). No injury when placing the tracheostomy by the surgeon (based on the results of case reports and observation). Level of consciousness between 4 and 8 (determination of the level of consciousness is according to the routine and existing ICU sheets using the Glasgow Coma Scale). Age group of young and middle-aged people between 18 and 60 years. Not receiving sedatives, neuromuscular blocking and anti-inflammatory drugs. No severe maxillofacial injuries. No underlying diseases (bleeding disorders, coagulation problems. arrhythmia, dysrhythmia, sensory motor disorders, etc.). No severe pulmonary problems and diseases (pulmonary obstructive disease, respiratory distress syndrome, etc.). Need for suction throughout the day and night as needed from the first day and for a maximum of 3 days. Consent of the patient's first-degree relatives to participate in the study.

Exclusion criteria

Exclusion criteria: Transfer of the patient to another medical facility or home. Change in level of consciousness to less than 4 or more than 8 (based on the Glasgow Coma Scale). Removal of the patient's tracheostomy tube. End of ventilation with a ventilator. Deterioration of the patient's condition, such as severe instability of vital signs or new diagnosis of any disease that causes the disease in the study. Failure of the patient or first-degree relatives to continue participating in the study. Patients who do not require at least 12 suctioning sessions within 3 days. Death of the patient.

Design outcomes

Primary

MeasureTime frame
The average pain score, measured by the Behavioral Pain Assessment Scale, will then be compared in the two groups. Timepoint: Pain score measurement on twelve occasions after the start of the study and up to a maximum of 72 hours later. Method of measurement: Behavioral Pain Scale.;The incidence of mucosal damage, which is recorded according to the observation checklist, with a score of one if there is blood in the suction catheter and a score of zero if no blood is observed. Timepoint: Measurement of mucosal damage score after each tracheostomy tube suction session for twelve sessions after the start of the study and up to a maximum of 72 hours later. Method of measurement: Observational checklist for assessing mucosal injury.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Shahriari

Zabol University of Medical Sciences

Shahriarireza944@gmail.com0098 54 3233456

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026