Acute Respiratory FailureKINEXTUBNCT05423301
Global Physiotherapy in ICU Patients With High Risk Extubation Failure
A study testing Experimental in people with Acute Respiratory Failure, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Experimental
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2023to 7 May 2026
- 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
- Patients with spontaneous ventilation weaning test.
- Consent form signed by the person support.
Who cannot join
- Patients with a self-extubation,
- Patients with a tracheostomy,
- Patients with acute respiratory failure for acute lung edema (OAP),
- Patients with decision to limit or stop Active Therapeutics (LATA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.
This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.
Read the detailed description
The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age > 65 years, respiratory disease, body mass index > 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored.
The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.
- Conditions
- Acute Respiratory Failure
- Being tested
- Experimental, Control
- Keywords
- Physiotherapy, Intensive care unit, Extubation, High-risk patients, Acute respiratory failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalProcedure or surgery
Respiratory care consists of manual and instrumental bronchial clearance techniques: Expiratory Flow Enhancement (EFE), suctioning, manual cough assist techniques, instrumental clearance techniques (suctioning and Cough Assist) and swallowing disorder management.)
ControlProcedure or surgery
The control group will receive early respiratory care and rehabilitation by nurses, nurses' aides and doctors until D7. Respiratory care includes aerosol therapy, oral and pharyngeal clearance with aspirations, verbal coughing and sputum removal, and possibly bronchial fibroscopy for clearance if necessary. Early rehabilitation consists of alternating postures in bed, passive chair positioning (patient lift), or active positioning via a bed rail and standing.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Procedure: Experimental |
| control | Active comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute respiratory failure
The primary endpoint is the proportion of patients with post-extubation acute respiratory failure, defined as the occurrence within 7 days of extubation of at least two of the following criteria: respiratory acidosis (pH <7.35, PaCO2 >45 mmHg), hypoxemia (PaO2 <60 mmHg with a FiO2 >40% or PaO2/FiO2<150) and respiratory rate >35/min.
Measured: During 7 days post extubation
Secondary outcomes (4)
ROX index
ROX index is calculated every 8 hours during the 7 days post-extubation, ROX index is defined by the ratio of oxygen saturation measured by pulse oximetry/FiO2 to respiratory rate.
Measured: 8 hours during 7 days post extubation
Rate of reintubation
The rate of reintubation within 7 days post-extubation, with reintubation occurring contemporaneously with the onset of acute respiratory failure, without expected clinical improvement,
Measured: During 7 days post extubation
Rate of pneumopathy
Lung disease is defined by the following criteria:
- Radiological signs : Two successive films from which the appearance of a focus of lung disease is suspected, If there is no history of heart or lung disease: one scan is sufficient.
- At least one of the following signs: temperature > 38.5° without other cause leukocytes < 4000/mm3 or > 12000/mm3
- And at least two of the following signs: Purulent secretions Cough or dyspnoea Desaturation or increased oxygen requirement or need for ventilatory support
Measured: During 7 days post extubation
Time for respiratory care
The mean time spent on respiratory care or mobilisation of patients estimated daily in the 7 days following extubation. Time estimated in minutes.
Measured: During 7 days post extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start3 Oct 2023
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Model description
- The proposed study will be a single-center open-label comparative randomized clinical study, in two parallel arms, at the Bordeaux University Hospital. Patients extubated during working hours on Mondays to Friday in the presence of the physiotherapy team will be included in the study and randomized with a 1: 1 ratio between the experimental arm and the control arm. In both groups, patients are routinely alternated between high-flow oxygenation and NIV, adjusted to patient-specific goals, as recommended for these patients.
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423301
- Sponsor's protocol ID
- CHUBX 2020/51
- Acronym
- KINEXTUB
- Status last verified
- May 2026
- First submitted
- 14 Jun 2022
- Last updated
- 14 May 2026
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.
- ClinicalTrials.gov ID
- NCT05423301
- Acronym / sponsor ID
- KINEXTUB / CHUBX 2020/51
- Conditions
- Acute Respiratory Failure
- Keywords
- Physiotherapy, Intensive care unit, Extubation, High-risk patients, Acute respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 21 Jun 2022 (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 aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.
Detailed description
The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age > 65 years, respiratory disease, body mass index > 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored.
The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study will be a single-center open-label comparative randomized clinical study, in two parallel arms, at the Bordeaux University Hospital. Patients extubated during working hours on Mondays to Friday in the presence of the physiotherapy team will be included in the study and randomized with a 1: 1 ratio between the experimental arm and the control arm. In both groups, patients are routinely alternated between high-flow oxygenation and NIV, adjusted to patient-specific goals, as recommended for these patients.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: Experimental |
| control | Active comparator | Procedure: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with spontaneous ventilation weaning test.
- Consent form signed by the person support.
Key exclusion criteria (4 listed)
- Patients with a self-extubation,
- Patients with a tracheostomy,
- Patients with acute respiratory failure for acute lung edema (OAP),
- Patients with decision to limit or stop Active Therapeutics (LATA).
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 |
|---|---|---|
| ExperimentalRespiratory care consists of manual and instrumental bronchial clearance techniques: Expiratory Flow Enhancement (EFE), suctioning, manual cough assist techniques, instrumental clearance techniques (suctioning and Cough Assist) and swallowing disorder management.) | Procedure or surgery | experimental |
| ControlThe control group will receive early respiratory care and rehabilitation by nurses, nurses' aides and doctors until D7. Respiratory care includes aerosol therapy, oral and pharyngeal clearance with aspirations, verbal coughing and sputum removal, and possibly bronchial fibroscopy for clearance if necessary. Early rehabilitation consists of alternating postures in bed, passive chair positioning (patient lift), or active positioning via a bed rail and standing. | Procedure or surgery | control |
Primary outcome
Rate of acute respiratory failure
Time frame: During 7 days post extubation
The primary endpoint is the proportion of patients with post-extubation acute respiratory failure, defined as the occurrence within 7 days of extubation of at least two of the following criteria: respiratory acidosis (pH <7.35, PaCO2 >45 mmHg), hypoxemia (PaO2 <60 mmHg with a FiO2 >40% or PaO2/FiO2<150) and respiratory rate >35/min.
4 secondary outcomes
ROX index
Time frame: 8 hours during 7 days post extubation
Rate of reintubation
Time frame: During 7 days post extubation
Rate of pneumopathy
Time frame: During 7 days post extubation
Time for respiratory care
Time frame: During 7 days post extubation
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 14 May 2026.
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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 Experimental in people with Acute Respiratory Failure, run by University Hospital, Bordeaux 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 2 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 14 May 2026. 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?
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?
Rate of acute respiratory failure (time frame: During 7 days post 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 14 May 2026.