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Percutaneous Dilatational Tracheostomy Early ComplicationsNCT07663461

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

An observational study of Percutaneous Dilatational Tracheostomy Early Complications, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Horizontal incision and percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Vertical incision
Type of treatment
Surgery or procedure
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2023to 1 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18 and over who are intubated in the Intensive Care Unit for various reasons and for whom tracheostomy is planned:

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa yüksek ihtisas educate ve resourches hospital BURSA, Bursa, Türkiye

    Bursa, Bursa, 16165

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Horizontal incision, percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Vertical incision
Keywords
Percutaneous dilatational tracheostomy, Griggs technique, Vertical incision, Horizontal incision, Intensive care unit, Early complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Horizontal incisionProcedure or surgery

    Also called Horizontal incision

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

  • percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Vertical incisionProcedure or surgery

    Also called Vertical incision

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

Study groups in NCT07663461
Study groupRoleWhat they receive
Group VVertical Incision Group
Receives: Procedure: percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Vertical incision
Group HHorizontal Incision Group
Receives: Procedure: percutaneous dilatational tracheostomy (PDT) via the Griggs technique -Horizontal incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding: During and after the incision process.

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

    Measured: First 24 hours after the procedure

Secondary outcomes (1)
  1. PDT process

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

    Measured: İntraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663461
Sponsor's protocol ID
2011 KAEK-25 2023/07-10
Status last verified
Jun 2026
First submitted
15 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sidam S, Nasi A, Gupta V, Saigal S, Sahoo AK, Mishra UP, Behera G. Impact of Vertical and Horizontal Skin Incisions on Outcome Measures in Tracheostomies. Cureus. 2024 Feb 13;16(2):e54142. doi: 10.7759/cureus.54142. eCollection 2024 Feb.

    PubMed 38496131

Questions about this trial

What is this clinical trial studying?

An observational study of Percutaneous Dilatational Tracheostomy Early Complications, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding: During and after the incision process. (time frame: First 24 hours after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07663461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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