TracheostomyREDECAPNCT02512744
Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)
A study testing Decannulation protocol. and High flow conditioned oxygen therapy in people with Tracheostomy and Airway Management, run by Hospital Virgen de la Salud at 5 sites in Spain.
Trial summary
Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols: 1. based on capping trials to decide decannulation, 2. based on the aspiration frequency to decide decannulation time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Airway Management, Respiratory Therapy
- What is being tested?
- Decannulation protocol. and High flow conditioned oxygen therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesSpain
- Study dates
- 1 May 2016to 1 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).
Who cannot join
- Patients consedered non-decannulable at time of randomization:
- unconscious patient (motor component of GCS score <6 points).
- Severe swallowing function (based on drink test).
- Airway patency problem (based of intolerance of occlusion test).
- Neuromuscular diseases.
- Patients with a Sabadell score >2.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Del Mar
Barcelona
Hospital Universitario Vall D´Ebron
Barcelona
Hospital Universitario de Ciudad Real
Ciudad Real
Hospital Universitario Ramon Y Cajal
Madrid
Hospital Virgen de La Salud
Toledo
About this study
Official title: Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:
- based on capping trials to decide decannulation,
- based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.
- Conditions
- Tracheostomy, Airway Management, Respiratory Therapy
- Being tested
- Decannulation protocol., High flow conditioned oxygen therapy
- Keywords
- Tracheostomy, Decannulation, Adult airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decannulation protocol.Procedure or surgery
Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours).
High flow conditioned oxygen therapyDevice
Also called OptiflowTM, Fisher&Paykel, Auckland, New Zealand.
High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol).
| Study group | Role | What they receive |
|---|---|---|
| Capping trial protocol | No intervention | Decannulation protocol based on tolerance to 24 hours capping trial to decide when to decannulate. Decapping during the capping trial for aspiration of respiratory secretions is considered a failure criteria of the trial. High flow conditioned oxygen therapy through tracheal cannula will be applied during periods out of capping trials. |
| Suctioning frequency protocol | Experimental | Decannulation protocol based on suctioning frequency to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours).
Intervention: suctioning frequency of respiratory secretions will be recorded untill fulfill decannulation criteria. Capping trials will not be allowed in this group.
High flow conditioned oxygen therapy will be applied through tracheal cannula during all the study period. Receives: Procedure: Decannulation protocol.; Device: High flow conditioned oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation time
Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation
Measured: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary outcomes (6)
Decannulation failure
Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100
Measured: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Intensive Care Unit Lenght of stay
Time since ICU admission to ICU discharge
Measured: Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital lenght of stay
Time since hospital admission to hospital discharge
Measured: Patients will be followed for the duration of hospital stay, an expected average of 3 months
ICU mortality
ICU mortality in every study group
Measured: Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital mortality
Hospital mortality in every study group
Measured: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Respiratory infection
Post-randomization pneumonia and tracheobronchitis rate in every study group
Measured: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start1 May 2016
- Primary completion1 May 2018
- Study completion1 May 2018
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 TracheostomyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Virgen de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Hernandez Martinez, Hospital Virgen de la Salud
- Investigators
- GONZALO HERNANDEZ, MD, Study chair, Hospital Virgen de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512744
- Sponsor's protocol ID
- 3/7/2015 n67
- Acronym
- REDECAP
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hernandez Martinez G, Rodriguez ML, Vaquero MC, Ortiz R, Masclans JR, Roca O, Colinas L, de Pablo R, Espinosa MD, Garcia-de-Acilu M, Climent C, Cuena-Boy R. High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation. N Engl J Med. 2020 Sep 10;383(11):1009-1017. doi: 10.1056/NEJMoa2010834.
PubMed 32905673
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)
- ClinicalTrials.gov ID
- NCT02512744
- Acronym / sponsor ID
- REDECAP / 3/7/2015 n67
- Conditions
- Tracheostomy, Airway Management, Respiratory Therapy
- Keywords
- Tracheostomy, Decannulation, Adult airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Hospital Virgen de la SaludUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:
- based on capping trials to decide decannulation,
- based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capping trial protocol | No intervention | –Decannulation protocol based on tolerance to 24 hours capping trial to decide when to decannulate. Decapping during the capping trial for aspiration of respiratory secretions is considered a failure criteria of the trial. High flow conditioned oxygen therapy through tracheal cannula will be applied during periods out of capping trials. |
| Suctioning frequency protocol | Experimental | Procedure: Decannulation protocol., Device: High flow conditioned oxygen therapyDecannulation protocol based on suctioning frequency to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours). Intervention: suctioning frequency of respiratory secretions will be recorded untill fulfill decannulation criteria. Capping trials will not be allowed in this group. High flow conditioned oxygen therapy will be applied through tracheal cannula during all the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).
Key exclusion criteria (6 listed)
- Patients consedered non-decannulable at time of randomization:
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 |
|---|---|---|
| Decannulation protocol.Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours). | Procedure or surgery | Suctioning frequency protocol |
| High flow conditioned oxygen therapyAlso: OptiflowTM, Fisher&Paykel, Auckland, New Zealand.High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol). | Device | Suctioning frequency protocol |
Primary outcome
Decannulation time
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation
6 secondary outcomes
Decannulation failure
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Intensive Care Unit Lenght of stay
Time frame: Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital lenght of stay
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
ICU mortality
Time frame: Patients will be followed for the duration of ICU stay, an expected average of 2 months
Hospital mortality
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
Respiratory infection
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 months
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 7 Aug 2018.
- Derived from this study: PubMed 32905673Hernandez Martinez G, Rodriguez ML, Vaquero MC, Ortiz R, Masclans JR, Roca O, Colinas L, de Pablo R, Espinosa MD, Garcia-de-Acilu M, Climent C, Cuena-Boy R. High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation. N Engl J Med. 2020 Sep 10;383(11):1009-1017. doi: 10.1056/NEJMoa2010834.
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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.
GONZALO HERNANDEZ, MD study chair
Hospital Virgen de la Salud
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decannulation protocol. and High flow conditioned oxygen therapy in people with Tracheostomy and Airway Management, run by Hospital Virgen de la Salud at 5 sites in Spain.
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 6 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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?
Decannulation time (time frame: Patients will be followed for the duration of hospital stay, an expected average of 3 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 NCT02512744, 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 7 Aug 2018; AzTrials last refreshed its copy on 30 Oct 2026.