Other Tracheostomy Complication Clinical Trial
Official title:
Percutaneous Tracheostomy - Systematic Comparison Among Two Methods: Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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