Percutaneous Dilatational Tracheotomy (PDT) Kit — Ciaglia Technique

The kit uses the Ciaglia serial dilation technique, which is the most widely adopted percutaneous dilatational tracheotomy method globally. The kit includes: a 14-gauge introducer needle with syringe, a J-wire guidewire (with flexible J-tip to prevent posterior tracheal wall injury), a series of progressive dilators (sizes 12Fr through 36Fr or equivalent), a bronchoscope introducer port (allowing fiber-optic guidance during the procedure), and a cuffed high-volume low-pressure (HVLP) tracheostomy tube in the selected inner diameter. All components are EO sterilized as a complete pre-assembled kit in a single tray pack.

Stock sizes: 6.0mm, 7.0mm, 8.0mm, and 9.0mm inner diameter (ID) cuffed tracheostomy tubes. Extended-length versions (for obese patients with deep neck tissue) and adjustable-flange tubes are available at 500 pcs MOQ with 30 to 45 day lead time. The tube outer diameter, cuff diameter, and flange dimensions are consistent with standard tracheostomy tube sizing conventions.

Bronchoscopic guidance is strongly recommended for the Ciaglia technique and is considered the standard of care in most ICU settings. The kit is designed to accommodate a flexible bronchoscope with a working channel of 2.8mm or larger, which is inserted through the tracheostomy tube before placement to provide real-time visualization of the posterior tracheal wall during guidewire insertion and dilation — significantly reducing the risk of posterior wall injury. The procedure can be performed without bronchoscopy by experienced operators using the palpation-landmark technique, but this is less safe for high-risk patients.

A high-volume low-pressure cuff inflates to a large diameter at low intracuff pressure (typically 20 to 30 cmH2O), distributing the sealing pressure over a larger area of tracheal mucosal surface. This contrasts with older high-pressure low-volume cuffs that caused ischemic pressure necrosis of the tracheal mucosa — the main cause of post-tracheotomy tracheal stenosis, a serious long-term complication. All our tracheostomy tubes use HVLP cuffs as standard. Intracuff pressure should be monitored and maintained below 30 cmH2O using a cuff pressure manometer.

The J-wire has a flexible, atraumatic J-shaped tip that deflects off the posterior tracheal wall rather than penetrating it — which is the primary risk of the standard Seldinger technique with a straight guidewire tip. After the introducer needle enters the tracheal lumen, the J-wire is advanced through the needle lumen; the flexible tip curls downward into the tracheal lumen rather than potentially perforating the posterior wall. This is a critical safety feature that makes the Ciaglia technique safer than earlier Seldinger approaches.

The tracheostomy tube remains in place for as long as the patient requires assisted ventilation or airway protection — which can range from days to months in ICU patients. The HVLP cuff maintains a seal for mechanical ventilation. Regular cuff pressure monitoring (every 8 hours) and tube care are required. Tube changes are typically performed at 7 to 14 days after initial placement when the tract has matured sufficiently.

Yes. Individual components — guidewires, serial dilators, tracheostomy tubes, introducer needles — are available in bulk for hospitals that use the kit components with their own institutional protocol variations. Contact us for component pricing and minimum quantities per item.

MOQ is 100 sets for standard OEM with custom peel-pack label. 500 sets for full tray insert printing with your brand. Lead time 14 to 21 days for branded kits. CE documentation under your product name supplied. Languages: English, Spanish, German, French, Arabic supported for IFU inserts.

CE declaration of conformity under EU MDR 2017/745, ISO 13485 manufacturing certificate, EO sterilization validation certificate, and batch certificate of analysis with dimensional and functional test data. Biocompatibility data per ISO 10993 for all catheter and tube materials available in technical file under NDA.

Percutaneous tracheotomy (PDT) is performed at the bedside in the ICU without requiring transfer to an operating room, reducing transport risk for critically ill patients. It uses a smaller incision than surgical tracheotomy, which generally results in less bleeding, fewer wound complications, and better cosmetic outcome. Meta-analyses consistently show PDT has equivalent or lower complication rates compared to surgical tracheotomy in selected ICU patients. The main contraindications to PDT are: morbid obesity with difficult neck anatomy, prior neck surgery or radiation, coagulopathy, and emergency airway situations where surgical tracheotomy is faster.

Both configurations are stocked. Serial dilation advances a sequence of dilators (12Fr through 36Fr or equivalent) over the guidewire, enlarging the stoma in controlled increments. The horn-shaped dilator does it in a single tapered pass, which shortens the dilation stage and means fewer component exchanges over the wire. The horn dilator has a soft tip — softer than tracheal forceps, reducing tissue injury during dilation — and a hydrophilic coating that lets it advance through the tissue tract more smoothly. Teams already trained on serial dilation generally stay with it; teams looking to shorten bedside procedure time ask for the horn configuration. Specify which you want at order — the rest of the kit contents are unchanged.

Three tube configurations: single lumen (model EKS-TRTP1A), double lumen (EKS-TRTP2A) and triple lumen (EKS-TRTP3A). All three are available across a 6.5 to 11.0mm inner diameter range in 0.5mm steps — 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5 and 11.0mm. Tube geometry is available in single or double curve. Lumen count, inner diameter and curve are specified at order.

10 sets for a standard configuration — low enough for a hospital to evaluate the kit in service, or for a distributor to test a market, before committing to volume. Custom kit builds with added instruments (scalpels, haemostatic forceps and other accessories to match your protocol) and OEM-branded runs with printed tray inserts carry the higher quantities described above. All products are supplied sterile in vacuum packaging.

EKINSUN manufactures complete PDT kits as OEM/ODM from Guangdong, China, with medical molding at an ISO 13485 certified partner facility — tube sizes, dilator style, tray contents and private labeling configured to your hospital protocol. If a standard catalog kit already matches your protocol, buy it off the shelf; a custom build is the right path when you need non-standard tube sizes, additional instruments in the tray, or your own brand on the pack. Minimum order 10 sets; OEM-branded runs ship in 21 to 30 days.