Airway ExtubationSEGEXNCT03946371
Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients (SEGEX)
An observational study of Airway Extubation and Pneumonia, Bacterial, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation, Pneumonia, Bacterial, Aspiration of Subglottic Secretions
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 1 Sep 2021
- 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: All patients admitted in intensive care intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours; and receiving mechanical ventilation for more than 48 hours. Planned extubations in the intensive care
Who may be able to join
- intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours
- mechanical ventilation for more than 48 hours
- planned extubations in the intensive care
Who cannot join
- age < 18 years
- terminal extubation
- Self extubation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Besancon
Besançon, Doubs, 25000
Clément VILLARET, +33789233860, clementvillaret@gmail.com
About this study
Official title: Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients
This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient.
Read the detailed description
Between 10 and 20% of patients develop extubation failure (10.7% in our ICU at 2018), which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. Tracheal secretions, LVEF<30%, MV > 7d, Weak of cough are identified as risk factors of extubation failures but are not completely performants. Avoiding reintubation remains an important clinical goal.
The subglottic secretion drainage above the cuff of an endotracheal tube is recognized as an effective method to prevent ventilator-associated pneumonia (VAP) in critically ill patients. The subglottic secretion drainage is used in a regular way in our ICU. Volume of subglottic secretion is not analysed in the scientific literature.
Study :
The investigators hypothesize that high volume of subglottic secretion before extubation is associated with high risk of extubation failure and à high risk of pneumonia post extubation.
All planned extubations in the intensive care unit after 2 days minimal of mechanic ventilation are recorded on a designated form and standard variables charted. All data will be collected retrospectively after the extubation event.
All included patients will be assigned a unique identification number (UID) by the investigator, who will secure the patient identifiers in an encrypted electronic file. The cause of extubation failure will be recorded (as identified by the attending physician on service, who is not involved in the study).
For statistical analysis, group that fail extubation, will be compared, with the group that was an extubation success. Standard demographics (age, sex), patient disease related factors (diagnosis, duration of intubation, secretions), care factors (cuff leak test, p/f ratio prior to extubation,LVEF<30% ), and post extubation care (post extubation respiratory support, stridor, blood gas, pneumonia) along with any complication during extubation and reintubation and reasons for reintubation will be collected and compared.
As two groups are being compared, bivariate analyses utilizing Chi-square tests or univariate logistic regression for categorical variables and Student t -tests for interval variables, will be done.
Investigators will perform an interim analysis at the end of 12 months and a final analysis
- Keywords
- Sub glottic secretions, Failure Extubation, endotracheal tube
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extubation Success | Patients who do not require re-intubation, upto 48 hours after a planned extubation in the adult intensive care unit. | |
| Extubation failure | Patients who required re-intubation within 48 hours after a planned extubation in adult intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
defined as a need for reintubation within 48 h after extubation
Measured: 48 hours
Volume of Subglottic Secretion
Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical
Measured: 24 weeks
Secondary outcomes (4)
Weaning mechanical ventilation failure
Use of non-invasive ventilation ( non-invasive ventilation / High-Flow Nasal Cannula) for curative purposes within 7 days after extubation or failure extubate within 72 hours (7 days if using NIV-HFNC)
Measured: 7 days
Pneumonia post extubation
If diagnosis retained by the doctor in charge of the patient and antibiotherapy set up for a duration of more than 5 days and occurred within 7 days post extubation
Measured: 7 days
Length of stay in ICU
Length of stay in ICU
Measured: 22 month
Mortality
Death
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start26 Apr 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ExtubationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Paillot, MD, Principal investigator, CHU Jean Minjoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946371
- Sponsor's protocol ID
- P/2019/429
- Acronym
- SEGEX
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients
- ClinicalTrials.gov ID
- NCT03946371
- Acronym / sponsor ID
- SEGEX / P/2019/429
- Keywords
- Sub glottic secretions, Failure Extubation, endotracheal tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 10 May 2019 (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.
This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient.
Detailed description
Between 10 and 20% of patients develop extubation failure (10.7% in our ICU at 2018), which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. Tracheal secretions, LVEF<30%, MV > 7d, Weak of cough are identified as risk factors of extubation failures but are not completely performants. Avoiding reintubation remains an important clinical goal.
The subglottic secretion drainage above the cuff of an endotracheal tube is recognized as an effective method to prevent ventilator-associated pneumonia (VAP) in critically ill patients. The subglottic secretion drainage is used in a regular way in our ICU. Volume of subglottic secretion is not analysed in the scientific literature.
Study :
The investigators hypothesize that high volume of subglottic secretion before extubation is associated with high risk of extubation failure and à high risk of pneumonia post extubation.
All planned extubations in the intensive care unit after 2 days minimal of mechanic ventilation are recorded on a designated form and standard variables charted. All data will be collected retrospectively after the extubation event.
All included patients will be assigned a unique identification number (UID) by the investigator, who will secure the patient identifiers in an encrypted electronic file. The cause of extubation failure will be recorded (as identified by the attending physician on service, who is not involved in the study).
For statistical analysis, group that fail extubation, will be compared, with the group that was an extubation success. Standard demographics (age, sex), patient disease related factors (diagnosis, duration of intubation, secretions), care factors (cuff leak test, p/f ratio prior to extubation,LVEF<30% ), and post extubation care (post extubation respiratory support, stridor, blood gas, pneumonia) along with any complication during extubation and reintubation and reasons for reintubation will be collected and compared.
As two groups are being compared, bivariate analyses utilizing Chi-square tests or univariate logistic regression for categorical variables and Student t -tests for interval variables, will be done.
Investigators will perform an interim analysis at the end of 12 months and a final analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation Success | – | –Patients who do not require re-intubation, upto 48 hours after a planned extubation in the adult intensive care unit. |
| Extubation failure | – | –Patients who required re-intubation within 48 hours after a planned extubation in adult intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in intensive care intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours; and receiving mechanical ventilation for more than 48 hours. Planned extubations in the intensive care
Key inclusion criteria (3 listed)
- intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours
- mechanical ventilation for more than 48 hours
- planned extubations in the intensive care
Key exclusion criteria (4 listed)
- age < 18 years
- terminal extubation
- Self extubation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation failure
Time frame: 48 hours
defined as a need for reintubation within 48 h after extubation
Volume of Subglottic Secretion
Time frame: 24 weeks
Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical
4 secondary outcomes
Weaning mechanical ventilation failure
Time frame: 7 days
Pneumonia post extubation
Time frame: 7 days
Length of stay in ICU
Time frame: 22 month
Mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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.
Jonathan Paillot, MD principal investigator
CHU Jean Minjoz
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 Airway Extubation and Pneumonia, Bacterial, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 10 May 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément VILLARET (+33789233860, clementvillaret@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 10 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.