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Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients.

Comparing the use of laryngeal mask airway (LMA) with tracheal tube to perform percutaneous dilatation tracheostomy (PDT) in brain trauma (TBI) patients.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211010052718N3
Enrollment
150
Registered
2023-09-03
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Diffuse traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: patients who are ventilated with a laryngeal mask, first the Endotracheal tube(ETT) was removed and then a Laryngeal mask airway(LMA Classic™) (purchased from Saba

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with brain injury hospitalized in the intensive care unit who need long-term respiratory care

Exclusion criteria

Exclusion criteria: Patients who had contraindications for Percutaneous DilatedTracheostomy included inadequate and difficult airway Patients who had contraindications forPercutaneous DilatedTracheostomy included obese subjects Patients with contraindications for Percutaneous DilatedTracheostomy included potentially difficult endotracheal intubation Patients with contraindications forPercutaneous DilatedTracheostomy included oxygenation index (Pascal Oxygen2/Fraction of Inspired Oxygen2) less than 200 Patients with contraindications for Percutaneous DilatedTracheostomy included positive end-expiratory pressure (Positive end-expiratory pressure ) =15 mbar

Design outcomes

Primary

MeasureTime frame
Determining the quality of tracheostomy. Timepoint: Before and after the presser. Method of measurement: Arterial blood gas levels.

Secondary

MeasureTime frame
Comparison of the amount of time of two methods. Timepoint: before and after. Method of measurement: Record the time of the procedure from the beginning to the end.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Nikzad

Mazandaran University of Medical Sciences

A.NIKZAD@MAZUMS.AC+98 11 3336 1700

Outcome results

None listed

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