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Status unknownNCT02802527Updated Jun 16, 2016

Percutaneous Tracheostomy - Systematic Comparison Among Two Methods

An interventional study of Percutaneous Tracheostomy in Other Tracheostomy Complication, sponsored by Hadassah Medical Organization. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.

In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.

So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.

Read the detailed description

Introduction Percutaneous dilatational tracheostomy (PDT) is routinely performed in most intensive care units in the world for a number of indications, such as: airway obstruction, need for long-term respiratory support, improvement in trachea-bronchial toilet, prophylaxis before head and neck procedures, cases of severe obstructive sleep apnea and poor neurological state.

Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical tracheostomy in the operating room.

In many places around the world it is customary to perform the procedure under direct visions via a bronchoscope to prevent damage to adjacent structures, ensure correct position of the tracheostomy tube, avoid damage to the posterior wall of the trachea and to confirm the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment and knowledge and skill of the operator. Use of the bronchoscope during the procedure may also result in complications such as temporary occlusion of the trachea and hypercarbia and increased duration of the procedure. Maintenance of the bronchoscope also carries associated costs (disinfection, replacement, etc.).

A retrospective review of 243 percutaneous tracheostomies done in trauma patients between January 2007 and December 2010 in whom 78 (32%) was performed with a bronchoscope and 168 (68%) without, found no differences between the groups 4.

Another retrospective study 5 looking only at percutaneous tracheostomies done without bronchoscopic guidance, analyzed 300 PDTs showed that 26 patients (8.6%) had complications, including: 2 (0.6%) patients deteriorated neurologically and 2 (0.6%) deaths were observed within 24 h following procedure. The median operating time was 3.5 min (range, 2.5-8 min). There were no cannula placement problems in any case . A retrospective study looking at 512 bronchoscopy guided procedures over 10 years concluded that: Eighteen patients (3.5%) presented procedural complications. Five patients experienced transient desaturation, 4 presented low blood pressure related to sedation, and 9 presented minor bleeding, but none required a transfusion. No serious complications or deaths associated with the procedure were recorded. Eleven patients (2.1%) presented post-operative complications. Seven presented minor and transitory bleeding of the percutaneous tracheostomy stoma, 2 suffered displacement of the tracheostomy cannula, and 2 developed a superficial infection of the stoma.

In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.

So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.

02

Conditions studied

  • Other Tracheostomy Complication
03

In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
  • Minimal age 18

Exclusion criteria

Exclusion Criteria:

  • No patient consent for participation
  • Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Bronchoscopy Guided

    Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire.

    Procedure: Percutaneous Tracheostomy

  • Other
    Direct Laryngoscopy

    Performing percutaneous tracheostomy by placing the tube higher up, near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck.

    Procedure: Percutaneous Tracheostomy

Interventions

  • ProcedurePercutaneous Tracheostomy
06

What researchers measure

Primary outcomes

  1. A systematic comparison among the two methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity.

    Time frame: 30 days

Secondary outcomes

  1. Periprocedural Mortality.

    Time frame: 30 days.

  2. Post procedural ICU & Hospital length of stay.

    Time frame: 30 days.

  3. Complication rate comparison of PDT done in the ICU to PDT done in locations other than the ICU.

    Time frame: 30 days.

  4. Procedure's length.

    Time frame: 60 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02802527
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Jun 16, 2016
Start date
Jul 2016
Primary completion
May 2019 (estimated)
Last update
Jun 16, 2016
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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