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Completed

NCT Number: NCT07663461

COMPARİSON OF EARLY COMPLİCATİONS İN PERCUTANEOUS TRACHEOSTOMİES PERFORMED VİA VERTİCAL AND HORİZONTAL SKİN INCİSİONS

Airway management is critical for patients requiring prolonged mechanical ventilation in the intensive care unit (ICU) 1. Percutaneous dilatational tracheostomy (PDT) is the gold standard over surgical tracheostomy due to its lower complication rates, bedside applicability, and cost-effectiveness. Currently, the Griggs technique is one of the most widely used PDT methods. Despite its advantages, early complications such as bleeding, airway injury, accidental decannulation, subcutaneous emphysema, and difficult cannulation can still occur.

There is no consensus in the literature regarding the optimal skin incision orientation (vertical vs. horizontal) during PDT. Vertical incisions are hypothesized to reduce bleeding risk due to the longitudinal course of the anterior jugular veins. Conversely, horizontal incisions are suggested to achieve better wound healing and minimal scarring by aligning with Langer's lines. However, clinical evidence comparing these two approaches remains limited and contradictory.

The primary objective of this study was to compare vertical and horizontal skin incisions in PDT performed with the Griggs technique regarding early complications within the first 24 hours postoperatively. The secondary objectives were to evaluate the impact of incision type on the dilation process, the number of dilation attempts, and the ease of tracheostomy tube insertion.

MATERIALS AND METHODS Study Design and Ethical Approval This single-center, prospective, observational cohort study was conducted in the Anesthesiology and Reanimation Intensive Care Unit (ICU) of University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital between September 1, 2023, and September 1, 2024. Approval was obtained from the Institutional Review Board (Decision No: 2011 KAEK-25 2023/07-10) in accordance with the Declaration of Helsinki principles and the STROBE guidelines. Written and/or oral informed consent was obtained from all patients or their first-degree relatives. Patients were divided into two groups based entirely on the attending physician's clinical preference regarding the skin incision orientation: the Vertical Incision Group (Group V, n=37) and the Horizontal Incision Group (Group H, n=37).

Data Collection and Parameters A standardized case report form was prospectively completed for each patient. Recorded variables included demographic characteristics (age, gender, body mass index [BMI]), comorbidities, reasons for ICU admission, APACHE II and SOFA scores, perioperative anticoagulant/antiplatelet use, and the timing and indication of tracheostomy. Complete blood count, PT, aPTT, and INR values on the morning of the procedure were recorded. Hemodynamic data (heart rate, systolic, diastolic, and mean blood pressures), oxygen saturation (SpO₂), and arterial blood gas parameters (PCO₂, PaO₂) were monitored before, during, and at 0, 6, 12, and 24 hours post-procedure. Procedural variables (incision type, bleeding, and dilation status) and all early complications occurring within the first 24 hours (cannula malposition, subcutaneous emphysema, pneumothorax/pneumomediastinum, posterior tracheal wall injury, submucosal guidewire placement, and postoperative incision site bleeding) were systematically recorded.

Percutaneous Tracheostomy Procedure All tracheostomies were performed at the bedside under elective conditions by an anesthesia resident with at least 2.5 years of experience who had performed at least 10 prior tracheostomies, accompanied by an experienced anesthesia or intensive care specialist.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa yüksek ihtisas educate ve resourches hospital BURSA, Bursa, Türkiye

Bursa, 16165, Turkey (Türkiye)

About this study

Percutaneous Tracheostomy Procedure All tracheostomies were performed at the bedside under elective conditions by an anesthesia resident with at least 2.5 years of experience who had performed at least 10 prior tracheostomies, accompanied by an experienced anesthesia or intensive care specialist. A commercially available percutaneous tracheostomy kit (Portex, Hythe, Kent, UK) was used. Before the procedure, intravenous fentanyl (2 µg kg-1), midazolam (0.05-0.1 mg kg-1), and rocuronium (0.6 mg kg-1) were administered for sedation and neuromuscular blockade; FiO₂ was increased to 100%, and the mechanical ventilation (MV) was switched to controlled mode. The patient was placed in the supine position, and a horizontal shoulder roll was used to achieve neck extension.

After deflating the cuff, the endotracheal tube was withdrawn to just below the vocal cords, and the cuff was re-inflated by a bedside assistant. Under full sterile precautions (including mask, cap, sterile gown, and gloves), the surgical field was disinfected using povidone-iodine and isolated with sterile drapes. Following palpation of the tracheal cartilage, local anesthesia was applied to the insertion site using 2-3 mL of 2% lidocaine with 1/100,000 adrenaline. An 8-10 mm horizontal or vertical skin incision was performed based on the clinician's preference. A 14-gauge needle attached to a syringe containing 3 mL of normal saline was advanced through a midline approach, and tracheal entry was confirmed by gas aspiration. The needle was removed, a guidewire was advanced into the trachea, and an 8F dilator was passed over the wire to expand the tract. The stoma was further expanded using Griggs forceps to dilate the skin, subcutaneous tissue, and tracheal opening. A size 7.5 or 8 tracheostomy cannula was inserted, the cuff was inflated, the airway was suctioned, and the patient was reconnected to MV. The stoma was cleaned and dressed with sterile gauze. Following a chest X-ray, patients were closely monitored for early complications for 24 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted to the Intensive Care Unit who are intubated for various reasons and for whom tracheostomy is planned.
  • Patients aged 18 and over.

Exclusion criteria

  • Patients for whom they or their first-degree relatives did not give consent.
  • Coagulation disorder (aPTT ≥35.5 sec, INR ≥1.5 or platelet count ≤50,000/mm3) ≤50,000/mm3)
  • Difficulty in neck lengthening
  • Spinal cord injury
  • Neck deformity (hematoma, tumor, thyroid enlargement)
  • Neck soft tissue infection
  • Local malignancy
  • Obesity
  • Short neck
  • History of previous tracheostomy
  • History of radiotherapy to the neck region

had difficulty with neck extension

had spinal cord injury had neck distortion (hematoma, tumor, thyromegaly) had neck soft tissue infection had local malignancy were obese or had a short neck

had a previous tracheostomy

had a history of radiotherapy to the neck

Treatment and study plan

percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Horizontal incision

Procedure

Comparing early complications of Horizontal skin incisions in Griggs PDT in the intensive care unit.

Other names: Horizontal incision

percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Vertical incision

Procedure

Comparing early complications of Vertical skin incisions in Griggs PDT in the intensive care unit.

Other names: Vertical incision

Primary outcomes

  1. Bleeding: During and after the incision process.

    Time frame: First 24 hours after the procedure

    • No bleeding
    • Oozing type bleeding
    • Bleeding controlled with 3-5 gauze pieces
    • Controlled with epinephrine/tranexamic acid gauze
    • Active bleeding requiring cautery/suture

Secondary outcomes

  1. PDT process

    Time frame: İntraoperative

    Ease of Dilation : Easy /Mild Resistance / Difficult Dilation Attempts : 1st / 2nd / ≥3rd Attempt Ease of Cannula Insertion : Easy /Mild Resistance / Difficult

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

COMPARİSON OF EARLY COMPLİCATİONS İN PERCUTANEOUS TRACHEOSTOMİES PERFORMED WİTH VERTİCAL OR HORİZONTAL SKİN INCİSİON İN THE INTENSİVE CARE UNİT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.