Airway ExtubationNCT05999526
Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial
A study testing Reconnection to mechanical ventilation for 1 hour and Direct extubation in people with Airway Extubation and Ventilator Weaning, run by Centro Hospitalar Unimed de Joinville at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation, Ventilator Weaning
- What is being tested?
- Reconnection to mechanical ventilation for 1 hour and Direct extubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Nov 2023to 15 Jun 2024
- 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
- Age > 18 years;
- Admission to the intensive care unit;
- Orotracheal intubation;
- Mechanical ventilation for more than 72 hours;
- Spontaneous breathing trial (according to the study protocol) successful and considered able to be extubated.
Who cannot join
- Patients unable to obey commands;
- Unplanned extubation;
- Neuromuscular disease and cervical spinal cord injury;
- Tracheostomy;
- Contraindication for cardiopulmonary resuscitation or reintubation;
- Absence of informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Hospitalar Unimed de Joinville
Joinville, Santa Catarina, 89204-061
About this study
Official title: Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: a Randomized Controlled Feasibility Trial
The aim of this study is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical ventilation. The study will compare two weaning strategies in critically ill participants admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:
- Reconnection to mechanical ventilation for 1 hour followed by extubation;
- Direct extubation.
Follow-up will be until hospital discharge or death.
- Conditions
- Airway Extubation, Ventilator Weaning
- Being tested
- Reconnection to mechanical ventilation for 1 hour, Direct extubation
- Keywords
- Rest, Ventilator Weaning, Airway Extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconnection to mechanical ventilation for 1 hourOther
As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated.
Direct extubationOther
The participant will be extubated immediately after the spontaneous breathing trial.
| Study group | Role | What they receive |
|---|---|---|
| Reconnection to mechanical ventilation for 1 hour | Experimental | As soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. Receives: Other: Reconnection to mechanical ventilation for 1 hour |
| Direct extubation | Active comparator | The participant will be extubated immediately after the spontaneous breathing trial. Receives: Other: Direct extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).
Measured: At day of extubation
Secondary outcomes (6)
Extubation failure within 7 days
Defined as a composite criterion of reintubation or death 7 days after extubation; Weaning failure will be defined as failure within 7 days after extubation requiring reintubation and invasive mechanical ventilation, whether post-extubation noninvasive ventilation was used or not. The choice of the composite outcome was made to consider possible participants who die before 7 days without being reintubated.
The choice of time for the 7-day outcome was based on the fact that the time interval to define extubation success varies in the literature, and on the evidence that many participants are reintubated after 48-72 hours, making these times early to assess reintubation, especially in cases of prophylactic use of noninvasive ventilation or post-extubation high flow nasal cannula.
Measured: Up to 7 days after extubation
Ventilator-free days in 28 days
Defined as the number of days from the time of extubation and initiation of unassisted breathing to day 28 after randomization. If a participant dies before day 28, days without ventilation will be counted as zero. If a participant is reintubated and returned to mechanical ventilation and is later extubated again and remains on unassisted breathing through day 28, ventilation-free days will be counted from the end of the last assisted breathing period through day 28. One period of invasive mechanical ventilation lasting less than 24 hours and for the purposes of the surgical procedure will count as 1 day free of mechanical ventilation. Participants who are discharged from the hospital on unassisted breathing before 28 days will be considered ventilator-free for the remaining days up to 28 days.
Measured: Up to 28 days after randomization
Length of stay in the intensive care unit
Length of hospital stay from randomization to intensive care unit discharge
Measured: At ICU discharge, up to 90 days
Length of hospital stay
Length of hospital stay from randomization to hospital discharge
Measured: At hospital discharge, up to 90 days
Mortality in the intensive care unit
Mortality from randomization to intensive care unit discharge
Measured: At intensive care unit discharge, up to 90 days
Hospital mortality
Mortality from randomization to hospital discharge
Measured: At hospital discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Nov 2023
- Primary completion22 Mar 2024
- Study completion15 Jun 2024
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions: 1. Reconnection to mechanical ventilation for 1 hour: as soon as the success of the spontaneous breathing trial is confirmed, the participants will be reconnected to mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. In the experimental group, in case there are signs of respiratory distress or other clinical problems during the resting phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation. 2. Direct extubation: participants will be extubated immediately after spontaneous breathing trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Unimed de Joinville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Braz Pereira, Centro Hospitalar Unimed de Joinville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999526
- Sponsor's protocol ID
- CHUnimed
- Other IDs
- 70984323.1.1001.5362
- Status last verified
- Feb 2024
- First submitted
- 12 Aug 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available after reasonable request and it has been discussed among the steering committee
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial: a Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05999526
- Acronym / sponsor ID
- CHUnimed
- Conditions
- Airway Extubation, Ventilator Weaning
- Keywords
- Rest, Ventilator Weaning, Airway Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Hospitalar Unimed de JoinvilleUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 21 Aug 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.
The aim of this study is to evaluate the feasibility to perform a future larger clinical trial to analyze whether the mechanical ventilation reconnection for 1 hour after a successful spontaneous breathing trial reduces the risk of reintubation or death at 7 days in participants with more than 72 hours of mechanical ventilation. The study will compare two weaning strategies in critically ill participants admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial:
- Reconnection to mechanical ventilation for 1 hour followed by extubation;
- Direct extubation.
Follow-up will be until hospital discharge or death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immediately after successful spontaneous breathing trial, eligible participants will be randomized into 2 groups that will undergo the following interventions: 1. Reconnection to mechanical ventilation for 1 hour: as soon as the success of the spontaneous breathing trial is confirmed, the participants will be reconnected to mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. In the experimental group, in case there are signs of respiratory distress or other clinical problems during the resting phase on mechanical ventilation, the intensivist may decide to keep the participant on mechanical ventilation for more than 1 hour until reassessing the appropriate time for extubation. 2. Direct extubation: participants will be extubated immediately after spontaneous breathing trial.
| Arm | Type | Receives |
|---|---|---|
| Reconnection to mechanical ventilation for 1 hour | Experimental | Other: Reconnection to mechanical ventilation for 1 hourAs soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. |
| Direct extubation | Active comparator | Other: Direct extubationThe participant will be extubated immediately after the spontaneous breathing trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years;
- Admission to the intensive care unit;
- Orotracheal intubation;
- Mechanical ventilation for more than 72 hours;
- Spontaneous breathing trial (according to the study protocol) successful and considered able to be extubated.
Key exclusion criteria (6 listed)
- Patients unable to obey commands;
- Unplanned extubation;
- Neuromuscular disease and cervical spinal cord injury;
- Tracheostomy;
- Contraindication for cardiopulmonary resuscitation or reintubation;
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 |
|---|---|---|
| Reconnection to mechanical ventilation for 1 hourAs soon as the success of the spontaneous breathing trial is confirmed, the participant will be kept on the mechanical ventilator for 1 hour using the previous ventilatory parameters and, afterwards, extubated. | Other | Reconnection to mechanical ventilation for 1 hour |
| Direct extubationThe participant will be extubated immediately after the spontaneous breathing trial. | Other | Direct extubation |
Primary outcome
Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups
Time frame: At day of extubation
Defined as the capability to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental group (mechanical ventilation reconnection for 1 hour [+/-10 min] after spontaneous breathing trial followed by extubation) and control (extubation immediately after spontaneous breathing trial).
6 secondary outcomes
Extubation failure within 7 days
Time frame: Up to 7 days after extubation
Ventilator-free days in 28 days
Time frame: Up to 28 days after randomization
Length of stay in the intensive care unit
Time frame: At ICU discharge, up to 90 days
Length of hospital stay
Time frame: At hospital discharge, up to 90 days
Mortality in the intensive care unit
Time frame: At intensive care unit discharge, up to 90 days
Hospital mortality
Time frame: At hospital discharge, up to 90 days
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 17 Feb 2025.
- Individual participant dataSharing planned: No. Data will be made available after reasonable request and it has been discussed among the steering committee
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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?
A study testing Reconnection to mechanical ventilation for 1 hour and Direct extubation in people with Airway Extubation and Ventilator Weaning, run by Centro Hospitalar Unimed de Joinville at 1 site in Brazil.
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 5 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 17 Feb 2025. 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 Brazil. 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?
Feasibility to complete the study according to the planned schedule and with adherence above 90% to the procedures of the experimental and control groups (time frame: At day of extubation). 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 17 Feb 2025.