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TracheostomyPhase 4NCT05343442

Percutaneous Tracheostomy

A Phase 4 study testing Percutaneous tracheostomy in people with Tracheostomy, run by Alexandria University at 1 site in Egypt.

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

Description of a technical modification of percutaneous tracheostomy that involves a safety method for confirming the intratracheal location of the needle at the time of puncture, with preventing serious complications such as false passage or damage to the posterior tracheal wall, without coadjuvant technique Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheostomy
What is being tested?
Percutaneous tracheostomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
1 siteEgypt
Study dates
19 Dec 2021to 15 Mar 2022
Phase
Phase 4
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

Who may be able to join

  • Clinical indication for tracheostomy

Who cannot join

  • Age <18, patients with severe coagulopathy, and unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors).

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria Faculty of Medicine

    Alexandria, 21651

Other trials in Egypt

About this study

Official title: A Novel Technique for Safe Blind Percutaneous Tracheostomy

Description of a technical modification of percutaneous tracheostomy that involves a safety method for confirming the intratracheal location of the needle at the time of puncture, with preventing serious complications such as false passage or damage to the posterior tracheal wall, without coadjuvant technique

Read the detailed description

Introduction:

Tracheotomy is one of the most common procedures used in the Intensive Care Unit (ICU). Since 1985, percutaneous tracheotomy (PT) has gained widespread acceptance as a method for creating a surgical airway, and new techniques for PT have been developed. Furthermore, the technique could be performed at the patient bedside, leading to a new way of viewing surgical access to the airway in the critically ill patient.

In 1985, Ciaglia described percutaneous dilatational tracheotomy (PDT). Five years later Griggs introduced tracheotomy using guidewire dilating forceps (GWDF). With this technique, the tracheostoma is opened using blunt-tipped forceps previously advanced over the metal guide in the tracheal lumen. In 1998 the classical technique of Ciaglia was modified using a single dilator with respect to the original technique, this modification offered the advantage that the stoma is produced by a single dilatation, thereby avoiding the need for successive dilatations.

PDT heralds many peri-procedural complications as bleeding, difficulty to place the tube, false passage, posterior tracheal wall injury, pneumothorax, pneumomediastinum, and subcutaneous emphysema. In view of preventing serious complications, fibro-bronchoscopy is the most widely used safety method, though its application as a routine coadjuvant technique is a subject of controversy, since the endoscopic guide produces a rise in airway pressure, hypoventilation, and an increase in intracranial pressure; a situation that contraindicates its utilization in some patients. Moreover, bronchoscopy increases the cost of the procedure. Capnography is useful for confirming the intratracheal location of the needle at the time of puncture. The disadvantage of capnography is the lack of direct visualization of the precise position of the needle and metal guide within the trachea. Ultrasound is a noninvasive procedure and can be useful for locating aberrant vascular structures.

One of the main advantages of percutaneous tracheotomy is bedside performance, thus eliminating the hazards, expenses, and logistics involved in operating room set-up usually required for open surgical tracheotomies. So, searching for a safe way without coadjuvant techniques is reasonable. Of note that a lot of ICUs don't have bronchoscopy or ultrasound machines routinely available. Aim of this study was to describe a novel technique for safe blind percutaneous tracheotomy without assisting tools.

Patients and methods:

Enrolled patients were admitted to Critical Care Medicine Department in Alexandria University Hospitals in the period from 1st January 2018 to 31st December 2021. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine was obtained. An informed consent was taken from the patients' next of kin before their enrollment in the study. All percutaneous tracheotomies were performed electively to intubated patients at the bedside. Inclusion criteria were adult patients ≥ 18 years indicated for tracheotomy. Exclusion criteria were obese patients with Body Mass Index (BMI) ≥ 45 kg/m2, severe coagulopathy, and unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors).

Data collection on enrollment was age, sex, body mass index (BMI), neck circumference, and indication for tracheostomy. Patients were sedated (midazolam 1-2 mg and fentanyl 100-200 mcg), paralyzed (atracurium 0.5 mg/Kg), and monitored by mainstream capnography, pulse oximetry and noninvasive blood pressure. Synchronized Intermittent Mandatory Ventilation (SIMV) mode was used, and the ventilator set to deliver 6-8mL/kg tidal volume, respiratory rate 16/minute, and fraction of inspired oxygen (FiO2) 100% starting 15 minutes before and until 5 minutes after the completion of the procedure. Proper pre-procedural suctioning from both endotracheal tube and mouth cavity was done.

Guidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention.

Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.

Novel technique for safe blind airway access:

After palpating the trachea through the incision, a 14- G cannula over needle was advanced caudally into trachea piercing and penetrating the rigid anterior wall of the endotracheal tube. Success of airway access was sudden loss of resistance while protecting the posterior tracheal wall by the posterior wall of the endotracheal tube with the non-dominant hand fixing the trachea during the process.

Endotracheal piercing of needle was confirmed by aspirating air bubbles into the saline filled syringe attached to the cannula over needle. Caudally directed needle position will be changed during gradual withdrawal of the endotracheal tube to release the cannula over needle off the anterior wall of the endotracheal tube. By this time, the proximal end of the cannula over needle penetrating the ETT will have been changed its direction cranially.

Successful full withdrawal of the cannula over needle from the anterior wall of the endotracheal tube was tested by smooth caudal redirection of the cannula over needle without any readvancement of the endotracheal tube. Caudal redirection of the cannula over needle is a mandatory step to ensure subsequent free passage of the guidewire into the trachea.

Upon successful release of the proximal end of cranially directed cannula over needle from the ETT, deflation of the ETT cuff and caudal redirection was mandatory for subsequent free passage of the guidewire into the trachea. To prevent injuring the bared posterior tracheal wall by the sharp needle' s tip during caudal redirection, one mm withdrawal of the needle out of the plastic cannula was done to make its proximal end non-traumatizing.

Proper caudal placement of the cannula over needle into the tracheal lumen was reconfirmed by aspirating air bubbles into the saline filled syringe attached to the cannula over needle once more. The needle was then removed leaving the cannula in place. The J-guidewire was inserted through the caudally directed cannula into the trachea. Cannula was subsequently removed.

The rest of the procedure was continued as usual: A 14- G dilator was passed over the guidewire to start stoma formation in the anterior tracheal wall. The Grigges' (guidewire dilating forceps) was advanced along the wire until resistance was felt at the anterior tracheal wall. The forceps was opened, and the pre-tracheal tissues were dilated. The forceps was removed, reapplied to the guidewire, and readvanced until the jaws were passed through the anterior tracheal wall. Opening the forceps to dilate the anterior tracheal wall was carried out. The forceps was removed, and the tracheostomy tube was loaded on the introducer dilator and passed into the trachea through the dilated stoma.

At this point the flexible introducer and the guidewire were removed, the cuff was inflated, and the ventilation was switched from the ETT to the tracheotomy tube. The endotracheal tube was completely removed after adequate ventilation through tracheotomy tube. Ventilation was confirmed by end expiratory volume on the ventilator and auscultation of the patient. The tracheotomy tube was secured in place with a neck band, and a chest radiograph was performed.

Procedure time was recorded with a digital stopwatch, (two times were recorded: 1-Novel Technique Time (NT Time): time from tracheal tube puncture till J-guidewire insertion into the trachea \& 2- Total Technique Time (TT Time): time from skin incision till tracheotomy tube insertion). Peri-procedural complications were recorded. They included procedure failure (with mentioning action taken to accomplish tracheotomy), cardiac arrest, bleeding (mention grades of bleeding), transient desaturation below 92%, false passage, and posterior tracheal wall injury. Furthermore, post-procedure chest radiograph was done to exclude pneumothorax, pneumomediastinum, and subcutaneous emphysema.

For safety purposes, bronchoscopy during the procedure was performed in the first twenty patients, to confirm midline tracheal puncture, changes in cannula over needle directions, integrity of the posterior tracheal wall, proper positioning of the guidewire, dilators, as well as tracheotomy tube while passing into the trachea.

Conditions
Tracheostomy
Being tested
Percutaneous tracheostomy
Keywords
Intensive care unit, Trachea, Tracheostomy, Tracheostomy cannula, Critically ill
Medical subject headings
Tracheal Diseases, Critical Illness

What participants receive

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

  • Percutaneous tracheostomyProcedure or surgery

    Guidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention.

    Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.

Study groups in NCT05343442
Study groupRoleWhat they receive
Patients assigned to percutaneous tracheostomyExperimentalGuidewire dilating forceps (Grigges') technique was the method which has been applied during our work. Proper positioning: patient's neck was extended as much as possible by placing a rolled towel between the shoulder blades, the patient's neck and the bed were maintained in neutral position. The operative site was sterilized before draping with 10% povidone iodine solution. Lidocaine 2% was used as local anesthetic prior to beginning the intervention. Transverse (1 cm) skin incision was made midway between the cricoid cartilage and the suprasternal notch, i.e., opposite the 2nd - 3rd or 3rd - 4th tracheal rings. Blunt dissection of subcutaneous fat and pre-tracheal tissue with mosquito clamp in a vertical direction was done till the tracheal rings were palpable.
Receives: Procedure: Percutaneous tracheostomy

What is being measured

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

  1. Percutaneous tracheostomy procedure

    Novel technique time: which is the time from tracheal tube puncture till J-guidewire insertion into the trachea

    Measured: 7 days

Secondary outcomes (1)
  1. Complications of the procedure

    Percentage of procedure failure Incidence of desaturation below 92 % Incidence of cardiac arrest Incidence of false passage Incidence of posterior tracheal wall injury Incidence of pneumothorax, pneumomediastinum and surgical emphysema

    Measured: 7 days

Timeline

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

  1. First posted25 Apr 2022
  2. Study start19 Dec 2021
  3. Primary completion15 Mar 2022
  4. Study completion15 Mar 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Observational study
Masking
None (open label)
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343442
Sponsor's protocol ID
0305355
Status last verified
Nov 2021
First submitted
13 Apr 2022
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sharing will be provided when required

Publications

  • Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.

    PubMed 3996056

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous tracheostomy in people with Tracheostomy, run by Alexandria University at 1 site in Egypt.

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 1 inclusion and 1 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 25 Apr 2022. 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 Egypt. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percutaneous tracheostomy procedure (time frame: 7 days). 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 NCT05343442, 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 25 Apr 2022.

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