Tracheostomy WeaningDECAP-ICUNCT05778682
Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit
A study testing Suctioning based protocol in people with Tracheostomy Weaning, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tracheostomy Weaning
- What is being tested?
- Suctioning based protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2023to 1 Feb 2025
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weaning from mechanical ventilation for at least 24 hours
- Randomisation must be done in 24 hours of the mechanical ventilation weaning.
Who cannot join
- Sabadell > 2
- Contraindication of decannulation : Glasgow Coma Scale <6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5H3
Karl Courchesne, 8199435275, karl.courchesne@usherbrooke.ca
Brian Grondin-Beaudoin
About this study
In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.
- Conditions
- Tracheostomy Weaning
- Being tested
- Suctioning based protocol, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suctioning based protocolProcedure or surgery
cf. arm The necessity of suctioning will be assed continuously by the nurses, respiratory therapist and the medical team. If the patient require 2 or less aspiration each 8 hours for 24 hours straight, an attempt of decanalution will be done.
Usual CareProcedure or surgery
Usual care in our center is tolerance to a capping trial.
| Study group | Role | What they receive |
|---|---|---|
| Suction based protocol | Experimental | Weaning protocol based on suctioning frequency. Once the weaning of mechanical ventilation, the patients in this arm will be on high-flow nasal canula. The canula will be remove if the decannulation conditions are met (if the patient require less than 2 aspirations in 8 hours for 24 consecutive hours) Receives: Procedure: Suctioning based protocol |
| Usual care | Other | Usual care will mainly base on the capping trial. Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to decannulation
Time between the randomisation and the decannulation
Measured: Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.
Secondary outcomes (8)
Time to decannulation criteria
Time between the randomisation and the criteria of decannulation
Measured: From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months.
Length of stay ICU
Lenght of stay in the ICU.
Measured: From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.
Length of stay hospital
Length of stay in the hospital
Measured: From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months.
ICU readmission
ICU readmission
Measured: Through study completion, average of 6 to 12 months.
Decannulation failure
Necessity of reimplantation of a tracheostomy after the decannulation
Measured: Through study completion, average of 6 to 12 months.
Mechanical Ventilation weaning failure
Necessity of starting mechanical ventilation once the randomisation is started
Measured: Through study completion, average of 6 to 12 months.
Adverses effects
Pneumonia, sepsis, septic shock
Measured: Through study completion, average of 6 to 12 months.
Mortality
All cause mortality
Measured: Through study completion, average of 6 to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start20 Mar 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy WeaningStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778682
- Sponsor's protocol ID
- 2022-4213
- Acronym
- DECAP-ICU
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
PubMed 30115127Hosokawa K, Nishimura M, Egi M, Vincent JL. Timing of tracheotomy in ICU patients: a systematic review of randomized controlled trials. Crit Care. 2015 Dec 4;19:424. doi: 10.1186/s13054-015-1138-8.
PubMed 26635016Mahmood K, Wahidi MM. The Changing Role for Tracheostomy in Patients Requiring Mechanical Ventilation. Clin Chest Med. 2016 Dec;37(4):741-751. doi: 10.1016/j.ccm.2016.07.013. Epub 2016 Oct 14.
PubMed 27842753Spataro E, Durakovic N, Kallogjeri D, Nussenbaum B. Complications and 30-day hospital readmission rates of patients undergoing tracheostomy: A prospective analysis. Laryngoscope. 2017 Dec;127(12):2746-2753. doi: 10.1002/lary.26668. Epub 2017 May 23.
PubMed 28543108Simon M, Metschke M, Braune SA, Puschel K, Kluge S. Death after percutaneous dilatational tracheostomy: a systematic review and analysis of risk factors. Crit Care. 2013 Oct 29;17(5):R258. doi: 10.1186/cc13085.
PubMed 24168826Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
PubMed 22990518Ceriana P, Carlucci A, Navalesi P, Rampulla C, Delmastro M, Piaggi G, De Mattia E, Nava S. Weaning from tracheotomy in long-term mechanically ventilated patients: feasibility of a decisional flowchart and clinical outcome. Intensive Care Med. 2003 May;29(5):845-8. doi: 10.1007/s00134-003-1689-z. Epub 2003 Mar 13.
PubMed 12634987Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.
PubMed 31591659Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.
PubMed 30617626Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PubMed 20667153Trouillet JL, Collange O, Belafia F, Blot F, Capellier G, Cesareo E, Constantin JM, Demoule A, Diehl JL, Guinot PG, Jegoux F, L'Her E, Luyt CE, Mahjoub Y, Mayaux J, Quintard H, Ravat F, Vergez S, Amour J, Guillot M. Tracheotomy in the intensive care unit: guidelines from a French expert panel. Ann Intensive Care. 2018 Mar 15;8(1):37. doi: 10.1186/s13613-018-0381-y.
PubMed 29546588Yang A, Gray ML, McKee S, Kidwai SM, Doucette J, Sobotka S, Yao M, Iloreta A. Percutaneous versus surgical tracheostomy: timing, outcomes, and charges. Laryngoscope. 2018 Dec;128(12):2844-2851. doi: 10.1002/lary.27334. Epub 2018 Oct 3.
PubMed 30284256Adly A, Youssef TA, El-Begermy MM, Younis HM. Timing of tracheostomy in patients with prolonged endotracheal intubation: a systematic review. Eur Arch Otorhinolaryngol. 2018 Mar;275(3):679-690. doi: 10.1007/s00405-017-4838-7. Epub 2017 Dec 19.
PubMed 29255970
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decannulation of Tracheostomy Cannula Based on Suctioning Frequency and High-flow Oxygen Protocol in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05778682
- Acronym / sponsor ID
- DECAP-ICU / 2022-4213
- Conditions
- Tracheostomy Weaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 21 Mar 2023 (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.
In the DECAP-ICU trial, the investigators will be focusing on the impact of a new weaning tracheostomy technique based on suctioning frequency compared to the standard practice of capping tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suction based protocol | Experimental | Procedure: Suctioning based protocolWeaning protocol based on suctioning frequency. Once the weaning of mechanical ventilation, the patients in this arm will be on high-flow nasal canula. The canula will be remove if the decannulation conditions are met (if the patient require less than 2 aspirations in 8 hours for 24 consecutive hours) |
| Usual care | Other | Procedure: Usual CareUsual care will mainly base on the capping trial. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Weaning from mechanical ventilation for at least 24 hours
- Randomisation must be done in 24 hours of the mechanical ventilation weaning.
Key exclusion criteria (2 listed)
- Sabadell > 2
- Contraindication of decannulation : Glasgow Coma Scale <6, severe dysphagia, non permeable respiratory tracks, neuromuscular disease (expect for the ICU weakness) and long term tracheostomy.
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 |
|---|---|---|
| Suctioning based protocolcf. arm The necessity of suctioning will be assed continuously by the nurses, respiratory therapist and the medical team. If the patient require 2 or less aspiration each 8 hours for 24 hours straight, an attempt of decanalution will be done. | Procedure or surgery | Suction based protocol |
| Usual CareUsual care in our center is tolerance to a capping trial. | Procedure or surgery | Usual care |
Primary outcome
Time to decannulation
Time frame: Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.
Time between the randomisation and the decannulation
8 secondary outcomes
Time to decannulation criteria
Time frame: From date of randomisation to the date when the criteria of decannulation are met or to the date of death, whichever comes first, assessed up to 48 months.
Length of stay ICU
Time frame: From admission to the date when the patient quit the ICU, through study completion, average of 6 to 12 months.
Length of stay hospital
Time frame: From admission to the date when the patient is discharge of the hospital, through study completion, average of 6 to 12 months.
ICU readmission
Time frame: Through study completion, average of 6 to 12 months.
Decannulation failure
Time frame: Through study completion, average of 6 to 12 months.
Mechanical Ventilation weaning failure
Time frame: Through study completion, average of 6 to 12 months.
Adverses effects
Time frame: Through study completion, average of 6 to 12 months.
Mortality
Time frame: Through study completion, average of 6 to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 30115127Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
- Background: PubMed 26635016Hosokawa K, Nishimura M, Egi M, Vincent JL. Timing of tracheotomy in ICU patients: a systematic review of randomized controlled trials. Crit Care. 2015 Dec 4;19:424. doi: 10.1186/s13054-015-1138-8.
- Background: PubMed 27842753Mahmood K, Wahidi MM. The Changing Role for Tracheostomy in Patients Requiring Mechanical Ventilation. Clin Chest Med. 2016 Dec;37(4):741-751. doi: 10.1016/j.ccm.2016.07.013. Epub 2016 Oct 14.
- Background: PubMed 28543108Spataro E, Durakovic N, Kallogjeri D, Nussenbaum B. Complications and 30-day hospital readmission rates of patients undergoing tracheostomy: A prospective analysis. Laryngoscope. 2017 Dec;127(12):2746-2753. doi: 10.1002/lary.26668. Epub 2017 May 23.
- Background: PubMed 24168826Simon M, Metschke M, Braune SA, Puschel K, Kluge S. Death after percutaneous dilatational tracheostomy: a systematic review and analysis of risk factors. Crit Care. 2013 Oct 29;17(5):R258. doi: 10.1186/cc13085.
- Background: PubMed 22990518Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
- Background: PubMed 12634987Ceriana P, Carlucci A, Navalesi P, Rampulla C, Delmastro M, Piaggi G, De Mattia E, Nava S. Weaning from tracheotomy in long-term mechanically ventilated patients: feasibility of a decisional flowchart and clinical outcome. Intensive Care Med. 2003 May;29(5):845-8. doi: 10.1007/s00134-003-1689-z. Epub 2003 Mar 13.
- Background: PubMed 31591659Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.
- Background: PubMed 30617626Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Background: PubMed 20667153Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suctioning based protocol in people with Tracheostomy Weaning, run by Université de Sherbrooke at 1 site in Canada.
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 2 inclusion and 2 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 21 Mar 2023. 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to decannulation (time frame: Frome date of randomisation to the date of the actual decannulation or to the date of death, whichever comes first, assessed up to 48 months.). 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 NCT05778682, which also lists 27 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 21 Mar 2023.