Evaluation of the results of reducing the time of the first tracheostomy tube change in children

Evaluation of the results of reducing the time of the first tracheostomy tube change from seven days to three days in one-day to fifteen year old children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231009059672N1

Enrollment

Registered

2023-10-19

Start date

2021-09-22

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Condition 1: Respiratory failure. Condition 2: Upper respiratory tract obstruction. Condition 3: Prolong intubation. Respiratory failure, not elsewhere classified Other diseases of upper respiratory tract

Interventions

Intervention 1: Control group: The first change of the tracheostomy tube on the 7th day. Intervention 2: Intervention group: First change of tracheostomy tube on the 3rd day.

Eligibility

Sex/Gender

All

Age

1 Days to 15 Years

Inclusion criteria

Inclusion criteria: Age between one day and 15 years Perform tracheostomy by ENT service Presence of tracheostomy indication Tracheostomy in children's medical center Consent of the patient's parents to participate in the study

Exclusion criteria

Exclusion criteria: Lack of parental consent Tracheostomy performed by a service other than ENT Performing tracheostomy outside the children's medical center

Design outcomes

Primary

Measure	Time frame
Short-term complications after tracheostomy (such as bleeding, expansion of air in the interstitium, obstruction of the tracheostomy tube, accidental decannulation). Timepoint: The first week after tracheostomy. Method of measurement: Clinical visit.;Long-term complications after tracheostomy (such as wound complications around the tracheostomy site, granulation tissue around the stoma). Timepoint: From one week after tracheostomy for at least 3 months. Method of measurement: Clinical visit.;Length of stay in ICU. Timepoint: Length of stay in ICU after tracheostomy. Method of measurement: Clinical visit.;Duration of hospitalization. Timepoint: Hospitalization period after tracheostomy. Method of measurement: Clinical visit.;Duration of sedation after surgery. Timepoint: After tracheostomy until the cessation of sedative drugs. Method of measurement: Clinical visit.;Discharge status. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit.;Time of decannulation. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit.	—

Measure

Time frame

Short-term complications after tracheostomy (such as bleeding, expansion of air in the interstitium, obstruction of the tracheostomy tube, accidental decannulation). Timepoint: The first week after tracheostomy. Method of measurement: Clinical visit.;Long-term complications after tracheostomy (such as wound complications around the tracheostomy site, granulation tissue around the stoma). Timepoint: From one week after tracheostomy for at least 3 months. Method of measurement: Clinical visit.;Length of stay in ICU. Timepoint: Length of stay in ICU after tracheostomy. Method of measurement: Clinical visit.;Duration of hospitalization. Timepoint: Hospitalization period after tracheostomy. Method of measurement: Clinical visit.;Duration of sedation after surgery. Timepoint: After tracheostomy until the cessation of sedative drugs. Method of measurement: Clinical visit.;Discharge status. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit.;Time of decannulation. Timepoint: Patient follow-up up to 3 months after tracheostomy. Method of measurement: Clinical visit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeynab Agahi Kesheh

Tehran University of Medical Sciences

z_a_k_1991@yahoo.com+98 21 6119 2393

Outcome results

None listed

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