Respiratory FailureNCT04987398
Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU
An observational study of Respiratory Failure and Tracheostomy Complication, run by Piquilloud Imboden Lise at 1 site in Switzerland.
Trial summary
This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Tracheostomy Complication
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jun 2021to 15 May 2022
- 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 to the Lausanne ICU between May1st and November 31st who had a tracheotomy and were ventilated for more than 72 hours were screened for exclusion criterias. 147 patients were screened and 80 patients were included.
Who may be able to join
- All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.
Who cannot join
- Presence of a know opposition to participation to research projects
- Patient tracheostomized specifically for ENT (ear-nose-throat) reason
- Burn victim
- Patient tracheostomized before his/her admission to the Lausanne ICU
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Official title: Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital
This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.
- Conditions
- Respiratory Failure, Tracheostomy Complication
- Keywords
- Tracheostomy, Ventilation weaning, spontaneous breathing trial
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| Intubation for respiratory reasons | All patients who were intubated for respiratory reasons (i.e. acute respiratory distress syndrome, pneumonias, pleural effusions for example) | |
| Intubation for neurological reasons | All patients who were intubated for neurological reasons (i.e. stroke, intracranial bleeding, cervical fracture with tetraparesia for example) | |
| Intubation for other reasons | All patients who were intubated for other reasons than respiratory or neurological (i.e. intubation before surgery, cardiac arrest, hemodynamic instability and polytraumatism without respiratory distress or neurological pathology necessitating intubation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from intubation to tracheotomy
Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours
Measured: Once, between time of intubation to time of tracheotomy, up to 60 days
Secondary outcomes (27)
Age
Collected from electronic patient files.
Measured: At ICU admission
Weight
Collected from electronic patient files.
Measured: At ICU admission
Height
Collected from electronic patient files.
Measured: At ICU admission
Body mass index
Calculated from weight and height
Measured: At ICU admission
Predicted body weight (PBW)
Calculated as such :
Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)
Measured: At ICU admission
SOFA score (admission)
Calculated at admission
Measured: At ICU admission
Clinical Frailty Score
Calculated at ICU admission
Measured: At ICU admission
Charlson comorbidity index
Calculated at ICU admission
Measured: At ICU admission
Comorbidities
Collected at ICU admission
Measured: At ICU admission
Ventilation modalities and settings from intubation to tracheotomy
Ventilation modalities and settings recolted from electronic patient files.
Measured: Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Sedation opioid use from intubation to tracheotomy
Sedation use collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Opioid use from intubation to tracheotomy
Opioid use collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Neuromuscular blocking agent use from intubation to tracheotomy
Neuromuscular blocking agent use collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Tracheotomy time
Collected from electronic patient files (day and hour)
Measured: At time of tracheotomy, once, up to 60 days after intubation day
Tracheotomy type (percutaneous, surgical)
Collected from electronic patient files.
Measured: At time of tracheotomy, once, up to 60 days after intubation day
Ventilation settings and modalities from day of tracheotomy
Collected from electronic patient files.
Measured: 2 hours before tracheotomy
SOFA score (tracheotomy day)
Calculated from electronic patient files.
Measured: Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning
Ventilation modalities and settings collected from electronic patient files.
Measured: Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning
Data collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Physical therapy sessions from tracheotomy to mechanical ventilation weaning
Data collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Mechanical ventilation weaning day
Data collected from electronic patient files.
Measured: Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
SOFA score (mechanical ventilation weaning day)
Calcutated from electronic patient files.
Measured: Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death
Collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death
Collected from electronic patient files.
Measured: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Hospital stay duration
Collected from electronic patient files and discharge letters
Measured: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Outcome and specific treatments in ICU
Data recolted from electronic patient files
Measured: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Correlation of ventilation settings and modalities and tracheotomy weaning strategies
Collected from electronic patient files and discharge letters
Measured: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start10 Jun 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piquilloud Imboden Lise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piquilloud Imboden Lise, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987398
- Sponsor's protocol ID
- TRACH-CHANGE
- Status last verified
- Aug 2021
- First submitted
- 12 Jul 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1(1):CD007271. doi: 10.1002/14651858.CD007271.pub3.
PubMed 25581416Arabi Y, Haddad S, Shirawi N, Al Shimemeri A. Early tracheostomy in intensive care trauma patients improves resource utilization: a cohort study and literature review. Crit Care. 2004 Oct;8(5):R347-52. doi: 10.1186/cc2924. Epub 2004 Aug 23.
PubMed 15469579Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Burns KEA, Soliman I, Adhikari NKJ, Zwein A, Wong JTY, Gomez-Builes C, Pellegrini JA, Chen L, Rittayamai N, Sklar M, Brochard LJ, Friedrich JO. Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis. Crit Care. 2017 Jun 1;21(1):127. doi: 10.1186/s13054-017-1698-x.
PubMed 28576127Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
PubMed 16606435McCredie VA, Alali AS, Scales DC, Adhikari NK, Rubenfeld GD, Cuthbertson BH, Nathens AB. Effect of Early Versus Late Tracheostomy or Prolonged Intubation in Critically Ill Patients with Acute Brain Injury: A Systematic Review and Meta-Analysis. Neurocrit Care. 2017 Feb;26(1):14-25. doi: 10.1007/s12028-016-0297-z.
PubMed 27601069Mehta AB, Walkey AJ, Curran-Everett D, Douglas IS. One-Year Outcomes Following Tracheostomy for Acute Respiratory Failure. Crit Care Med. 2019 Nov;47(11):1572-1581. doi: 10.1097/CCM.0000000000003959.
PubMed 31397716Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154.
PubMed 23695482
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital
- ClinicalTrials.gov ID
- NCT04987398
- Acronym / sponsor ID
- TRACH-CHANGE
- Conditions
- Respiratory Failure, Tracheostomy Complication
- Keywords
- Tracheostomy, Ventilation weaning, spontaneous breathing trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Piquilloud Imboden LiseUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 3 Aug 2021 (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 retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubation for respiratory reasons | – | –All patients who were intubated for respiratory reasons (i.e. acute respiratory distress syndrome, pneumonias, pleural effusions for example) |
| Intubation for neurological reasons | – | –All patients who were intubated for neurological reasons (i.e. stroke, intracranial bleeding, cervical fracture with tetraparesia for example) |
| Intubation for other reasons | – | –All patients who were intubated for other reasons than respiratory or neurological (i.e. intubation before surgery, cardiac arrest, hemodynamic instability and polytraumatism without respiratory distress or neurological pathology necessitating intubation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Lausanne ICU between May1st and November 31st who had a tracheotomy and were ventilated for more than 72 hours were screened for exclusion criterias. 147 patients were screened and 80 patients were included.
Key inclusion criteria (1 listed)
- All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.
Key exclusion criteria (4 listed)
- Presence of a know opposition to participation to research projects
- Patient tracheostomized specifically for ENT (ear-nose-throat) reason
- Burn victim
- Patient tracheostomized before his/her admission to the Lausanne ICU
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
Time from intubation to tracheotomy
Time frame: Once, between time of intubation to time of tracheotomy, up to 60 days
Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours
27 secondary outcomes
Age
Time frame: At ICU admission
Weight
Time frame: At ICU admission
Height
Time frame: At ICU admission
Body mass index
Time frame: At ICU admission
Predicted body weight (PBW)
Time frame: At ICU admission
SOFA score (admission)
Time frame: At ICU admission
Clinical Frailty Score
Time frame: At ICU admission
Charlson comorbidity index
Time frame: At ICU admission
Comorbidities
Time frame: At ICU admission
Ventilation modalities and settings from intubation to tracheotomy
Time frame: Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Sedation opioid use from intubation to tracheotomy
Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Opioid use from intubation to tracheotomy
Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Neuromuscular blocking agent use from intubation to tracheotomy
Time frame: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Tracheotomy time
Time frame: At time of tracheotomy, once, up to 60 days after intubation day
Tracheotomy type (percutaneous, surgical)
Time frame: At time of tracheotomy, once, up to 60 days after intubation day
Ventilation settings and modalities from day of tracheotomy
Time frame: 2 hours before tracheotomy
SOFA score (tracheotomy day)
Time frame: Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning
Time frame: Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning
Time frame: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Physical therapy sessions from tracheotomy to mechanical ventilation weaning
Time frame: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Mechanical ventilation weaning day
Time frame: Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
SOFA score (mechanical ventilation weaning day)
Time frame: Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death
Time frame: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death
Time frame: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Hospital stay duration
Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Outcome and specific treatments in ICU
Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Correlation of ventilation settings and modalities and tracheotomy weaning strategies
Time frame: Once, between day of hospital admission to day of hospital discharge, up to 2 years
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 3 Jun 2022.
- Background: PubMed 25581416Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015 Jan 12;1(1):CD007271. doi: 10.1002/14651858.CD007271.pub3.
- Background: PubMed 15469579Arabi Y, Haddad S, Shirawi N, Al Shimemeri A. Early tracheostomy in intensive care trauma patients improves resource utilization: a cohort study and literature review. Crit Care. 2004 Oct;8(5):R347-52. doi: 10.1186/cc2924. Epub 2004 Aug 23.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
- Background: PubMed 28576127Burns KEA, Soliman I, Adhikari NKJ, Zwein A, Wong JTY, Gomez-Builes C, Pellegrini JA, Chen L, Rittayamai N, Sklar M, Brochard LJ, Friedrich JO. Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis. Crit Care. 2017 Jun 1;21(1):127. doi: 10.1186/s13054-017-1698-x.
- Background: PubMed 16606435Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
- Background: PubMed 27601069McCredie VA, Alali AS, Scales DC, Adhikari NK, Rubenfeld GD, Cuthbertson BH, Nathens AB. Effect of Early Versus Late Tracheostomy or Prolonged Intubation in Critically Ill Patients with Acute Brain Injury: A Systematic Review and Meta-Analysis. Neurocrit Care. 2017 Feb;26(1):14-25. doi: 10.1007/s12028-016-0297-z.
- Background: PubMed 31397716Mehta AB, Walkey AJ, Curran-Everett D, Douglas IS. One-Year Outcomes Following Tracheostomy for Acute Respiratory Failure. Crit Care Med. 2019 Nov;47(11):1572-1581. doi: 10.1097/CCM.0000000000003959.
- Background: PubMed 23695482Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Failure and Tracheostomy Complication, run by Piquilloud Imboden Lise at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 3 Jun 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 Switzerland. 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?
Time from intubation to tracheotomy (time frame: Once, between time of intubation to time of tracheotomy, up to 60 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 NCT04987398, which also lists 8 linked publications.
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 3 Jun 2022.