Respiratory FailureNCT03141294

Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy

A study testing reformative dilation technique in people with Respiratory Failure and Respiratory Depression, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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

Percutaneous dilatational tracheostomy (PDT), especially single-step dilatational tracheostomy (sd-PDT), is now frequently preferred to surgical tracheostomy. Occasionally, it needs a second dilation maneuver .Dissection of the deep cervical fascia during PDT, known as reformative PDT (re-PDT), may facilitate the… Read more about this study

Who is it for?: Ages 44 to 89 years
Conditions the study is for: Respiratory Failure, Respiratory Depression
What is being tested?: reformative dilation technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteChina
Study dates: 1 Jul 2012to 15 Feb 2017
Phase: Interventional
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 44 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age ≥18 years;
requirement for long-term mechanical ventilation;
failure of weaning from mechanical ventilation.

Who cannot join

age <18 years;
pre-existing infection at the tracheostomy site;
pre-existing malignancy at the tracheostomy site;
difficulty in identifying the anatomic landmarks;
unstable cervical spine fracture;
international normalized ratio (INR) >2;
platelet count <50 000 mm3.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affliated Hospital wiht Nanjing Medical University
Nanjing, Jiangsu

Other trials in China

About this study

Official title: Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial

Read the detailed description

Percutaneous dilatational tracheostomy (PDT) is a popular airway management technique in the intensive care unit (ICU).Occasionally the first dilation may be challenging when using Ciaglia and colleagues' method, and a second dilation may be needed to insert the tracheostomy tube. In these circumstances, potentially life-threatening complications, such as hemorrhage and hypoxia, may arise. The investigators found the reasons for difficulty in achieving smooth dilation of the stoma.The investigators compared the traditional method with the improved method.

Conditions: Respiratory Failure, Respiratory Depression
Being tested: reformative dilation technique
Keywords: tracheostomy，fascia，force gauge
Medical subject headings: Respiratory Insufficiency

What participants receive

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

reformative dilation techniqueProcedure or surgery
Also called reformative tracheostomy
reformative dilation technique was used when operating tracheostomy

Study groups in NCT03141294
Study group	Role	What they receive
sd-PDT group	Placebo comparator	The investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group. Receives: Procedure: reformative dilation technique
re-PDT group	Experimental	The investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group. Receives: Procedure: reformative dilation technique

What is being measured

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

Force(newton)
Force refers to the force needed to dilate the airway and measured by force gauge
Measured: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)

Secondary outcomes (1)

Time(seconds)
Time refers to the time needed to finish the whole step from tracheal puncture to tracheal tube placement
Measured: Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

Timeline

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

1 Jul 201215 Feb 2017

First posted5 May 2017
Study start1 Jul 2012
Primary completion30 Dec 2016
Study completion15 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03141294
Sponsor's protocol ID: 2017-SR-078
Status last verified: May 2017
First submitted: 20 Apr 2017
Last updated: 5 May 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.
PubMed 25946970

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reformative Versus Single Step Dilation Percutaneous Dilatational Tracheostomy: a Randomized Trial
ClinicalTrials.gov ID: NCT03141294
Acronym / sponsor ID: 2017-SR-078
Conditions: Respiratory Failure, Respiratory Depression
Keywords: tracheostomy，fascia，force gauge
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 1 Jul 2012 (actual)
Primary completion: 30 Dec 2016 (actual)
Study completion: 15 Feb 2017 (actual)
First posted: 5 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sd-PDT group	Placebo comparator	Procedure: reformative dilation techniqueThe investigators applied the traditional standard dilation technique when operating tracheostomy on the standard group.
re-PDT group	Experimental	Procedure: reformative dilation techniqueThe investigators applied the reformative dilation technique when operating tracheostomy on the re-PDT group.

Who may qualify

Ages: 44 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age ≥18 years;
requirement for long-term mechanical ventilation;
failure of weaning from mechanical ventilation.

Key exclusion criteria (7 listed)

age <18 years;
pre-existing infection at the tracheostomy site;
pre-existing malignancy at the tracheostomy site;
difficulty in identifying the anatomic landmarks;
unstable cervical spine fracture;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
reformative dilation techniqueAlso: reformative tracheostomyreformative dilation technique was used when operating tracheostomy	Procedure or surgery	re-PDT group, sd-PDT group

Primary outcome

Force(newton)
Time frame: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)
Force refers to the force needed to dilate the airway and measured by force gauge

1 secondary outcome

Time(seconds)
Time frame: Time was measured from tracheal puncture to tracheal tube placement, 180 seconds maxime

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Results publication: PubMed 25946970Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.
Individual participant dataSharing planned: Yes

Related trials for Respiratory Failure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jinhai Li study chair

The first Affliated Hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing reformative dilation technique in people with Respiratory Failure and Respiratory Depression, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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 3 inclusion and 7 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 5 May 2017. 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 China. 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. Some participants in this study may receive a placebo. 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?

Force(newton) (time frame: Intraoperative (Force was measured the exact moment when investigators insert the'J' guidewire)). 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 NCT03141294, 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 5 May 2017.