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

NCT07663461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2026-06-23

No results posted yet for this study

Summary

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.

Conditions

  • Percutaneous Dilatational Tracheostomy Early Complications

Interventions

PROCEDURE

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

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

PROCEDURE

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

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

Sponsors & Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663461 on ClinicalTrials.gov