The Comparison between two method of minisurgical percutaneous dilated tracheostomy

A double blind randomized controlled clinical trial study of comparison between two method of minisurgical percutaneous dilated tracheostomy, the standard method (Use of Tracheal Tube) or I gel insertion

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150107020592N8

Enrollment

Registered

2018-01-13

Start date

2017-10-12

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

The relationship between two methods of small throat surgery through the skin.

Interventions

Intervention 1: In the Conventional Method that will perform with ETT it will retract till to vocal cords to open enough space for the catheter insertion. Intervention 2: In Igel Method after the air

Treatment - Surgery

Treatment - Drugs

In the Conventional Method that will perform with ETT it will retract till to vocal cords to open enough space for the catheter insertion.

In Igel Method after the airway assessment and patient suctioning (to avoid aspiration),the Igel will lubricated by gelly lubricant and it will iuserted orally.

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients under mechanical ventilation which They will have needs to maintain the tracheal tube more than 1 week. Lacking evidence of ischemic heart disease. Without any damage to the cervical spine. Without morbid obesity. The PT , PTT, INR and platelet in normal range.

Exclusion criteria

Exclusion criteria: No inform consent; Failure in the relevant procedure.

Design outcomes

Primary

Measure	Time frame
The control of tracheal puncture. Timepoint: During the process. Method of measurement: Check list.;Duration of the procedure. Timepoint: During the process. Method of measurement: Based on minutes.;Peripheral blood oxygen saturation. Timepoint: During the process. Method of measurement: In terms of the oximeter pulse number.	—

Secondary

Measure	Time frame
Abnormal bleeding from Trachea. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Pneumothorax. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Subcutaneous emphysema. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Arrhythmia. Timepoint: During the procedure. Method of measurement: Based on electrocardiogram monitor monitoring.	—

Measure

Time frame

Abnormal bleeding from Trachea. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Pneumothorax. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Subcutaneous emphysema. Timepoint: During the procedure. Method of measurement: Based on clinical status.;Arrhythmia. Timepoint: During the procedure. Method of measurement: Based on electrocardiogram monitor monitoring.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Seyyed Mohammadreza Hashemian

Masih Daneshvari Hospital

iran.criticalcare@yahoo.com+98 27123101

Outcome results

None listed

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