TracheostomyNCT03244761
Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface
An observational study of Tracheostomy, run by Capital Medical University at 1 site in China.
Trial summary
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- The modified HFT
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 5 Feb 2018
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: The tracheostomized patient
Who may be able to join
- The tracheostomized patient requiring the convenient oxygen therapy.
Who cannot join
- Under 18 years;
- history of esophageal, gastric or lung surgery;
- The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.
Read the detailed description
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.
- Conditions
- Tracheostomy
- Being tested
- The modified HFT
- Keywords
- high flow tracheal oxygen, modified interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The modified HFTProcedure or surgery
The HFT was modified by increasing the expiratory resistance.
| Study group | Role | What they receive |
|---|---|---|
| The standard HFT | The high-flow oxygen was delivered via tracheostomy using a standard HFT. | |
| The modified HFT | The high-flow oxygen was delivered via tracheostomy using a modified HFT. Receives: Procedure: The modified HFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean end expiratory pressure.
The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.
Measured: the last 1 minutes of steady breathing during the standard or modified HFT.
Secondary outcomes (1)
Changes in global and regional EELV
The Electrical impedance tomography (EIT) was applied in monitoring the change of EELV at the bedside.
Measured: the last 1 minutes of steady breathing during the standard or modified HFT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Jul 2017
- Primary completion15 Sep 2017
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244761
- Sponsor's protocol ID
- KY-2017-CC-13
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of High-Flow Tracheal Oxygen Via An Modified Interface in Tracheostomized Patients
- ClinicalTrials.gov ID
- NCT03244761
- Acronym / sponsor ID
- KY-2017-CC-13
- Conditions
- Tracheostomy
- Keywords
- high flow tracheal oxygen, modified interface
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 10 Aug 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.
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.
Detailed description
Tracheostomy is often performed in patients after or anticipated prolonged mechanical ventilation, who are usually required oxygen therapy after discontinuation of mechanical ventilation.The high-flow tracheal (HFT) oxygen therapy in tracheostomized patients has been shown that can improve oxygenation,but can not induce positive end-expiratory pressure and elevation of end-expiratory lung volume. A modified HFT system by increasing expiratory resistance might induce PEEP and consequently elevate EELV.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The standard HFT | – | –The high-flow oxygen was delivered via tracheostomy using a standard HFT. |
| The modified HFT | – | Procedure: The modified HFTThe high-flow oxygen was delivered via tracheostomy using a modified HFT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The tracheostomized patient
Key inclusion criteria (1 listed)
- The tracheostomized patient requiring the convenient oxygen therapy.
Key exclusion criteria (3 listed)
- Under 18 years;
- history of esophageal, gastric or lung surgery;
- The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
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 |
|---|---|---|
| The modified HFTThe HFT was modified by increasing the expiratory resistance. | Procedure or surgery | The modified HFT |
Primary outcome
The mean end expiratory pressure.
Time frame: the last 1 minutes of steady breathing during the standard or modified HFT.
The patients was delivering the high flow oxygen via the standard and modified HFT interface for 20 minutes.
1 secondary outcome
Changes in global and regional EELV
Time frame: the last 1 minutes of steady breathing during the standard or modified HFT.
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 12 Feb 2018.
Related trials for Tracheostomy
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients
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.
Jian-Xin Zhou, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy, run by Capital 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 1 inclusion and 3 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 12 Feb 2018. 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. 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?
The mean end expiratory pressure. (time frame: the last 1 minutes of steady breathing during the standard or modified HFT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2018.