High-risk for Reintubation PatientsNCT03908658
Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning
A study testing Inspiratory muscle Training and Nasal High Flow and Inspiratory muscle training and Venturi mask in people with High-risk for Reintubation Patients and Weaning Outcome, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-risk for Reintubation Patients, Weaning Outcome
- What is being tested?
- Inspiratory muscle Training and Nasal High Flow and Inspiratory muscle training and Venturi mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2019to 20 Mar 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >65 years,
- BMI> 35kg/m2,
- weak cough,
- heart (i.e heart failure ) and lung comorbidities (i.e COPD),
- hypercapnia during mechanical ventilation
- > 72hours on mechanical ventilation
- failed first spontaneous breathing trial
Who cannot join
- Glasgow Coma scale (GCS)<13,
- pre-existing neuromuscular disease or deformity of Spinal Cord,
- terminal disease
- hemodynamic instability with >0.1μg/kg/min noradrenaline
- patients of immediately need of Non-invasive ventilation after extubation
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Evangelismos Hospital
Athens, 10676
Anna Christakou, +306977370284, achristakou@phed.uoa.gr
Irini Patsaki, +306942064363, ipatsaki@yahoo.gr
About this study
Official title: The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients
The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.
Read the detailed description
20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.
Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.
A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.
- Being tested
- Inspiratory muscle Training and Nasal High Flow, Inspiratory muscle training and Venturi mask
- Keywords
- inspiratory muscle training, Nasal High Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle Training and Nasal High FlowOther
Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght
Inspiratory muscle training and Venturi maskDevice
Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training and Nasal High Flow | Active comparator | Inspiratory Muscle Training will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Nasal High Flow will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU Receives: Other: Inspiratory muscle Training and Nasal High Flow |
| Inspiratory Muscle Training and Venturi mask | Active comparator | IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Venturi mask will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU Receives: Device: Inspiratory muscle training and Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weaning failure
Rate of weaning failure in high-risk for reintubation patients
Measured: 48 hours after extubation
Secondary outcomes (7)
Maximal Inspiratory Pressure
Maximal Inspiratory Pressure (MIP) will be assessed witn an unidirectional expiratory valve which permit exhalation while inspiration is blocked. One side of the valve will be attached to the patient's endotracheal tube and the other side to a manometer. Manometer could register pressures from 0 to 60 cmH20. Patients will be disconnected from the ventilator and attached to the valve for a period of more than 30 sec. The most negative value will be recorded
Measured: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Maximal Expiratory Pressure
Maximal Expiratory Pressure (MEP) will be assessed witn an unidirectional inspiratory valve which permit inspiration while expiration is blocked. One side of the valve will be attached to the patient's endotracheal tube and the other side to a manometer. Manometer could register pressures from 0 to 60 cmH20. Patients will be disconnected from the ventilator and attached to the valve for a period of more than 30 sec. The highest value will be recorded
Measured: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Endurance of respiratory muscles
Endurance of respiratory muscles will be calculated comparing the preloading and postloading values of the MIP
Measured: Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge
Muscle strenght
Muscle strength will be assessed by the sum of Medical Research Council (MRC) scale for muscle strength in 6 different muscle groups ( shoulder abductors, forearm flexors, wrist flexors, hip flexors, knee extensors and plantar dorsiflexors) for both body sides. Each muscle group scores from 0 (no contraction) up to 5 (movement against gravity) and the total score range from 0 (worse outcome) up to 60 (best outcome)
Measured: Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge
Functional ability
Functional ability will be assessed by Functional Independence Measure (FIM) which includes 18 questions (13 motor tasks and 5 cognitive tasks). Each item is scored on a 7 point ordinal scale, ranging from a score of 1 (total inability-dependence) to a score of 7 (total independence). The higher the score, the more independent the patient is in performing the task associated with that item.The total score for the FIM motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91. The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 (total dependency) and 126 total indepedency
Measured: Within 24 hours after ICU discharge, within 24 hours before hospital discharge
Short Form 36 Health Survey (SF-36) questionnaire
Quality of life (QoL) will be assessed by Short Form 36 Health Survey (SF-36) which includes 36 items to measure 8 QoL domains. More specifically, from SF-36 only the domains parts of Physical Functioning (PF) which includes 10 questions with possible scores from 1 to 3, the Role Physical (RF) which includes 4 yes or no questions, the Social Functioning (SF) which includes 2 questions with possible scores form 1 to 5 and the Mental Health domain (MH) which includes 9 questions with possible scores form 1 to 9 will be used. Regarding the scoring of the questions 1 is the worst outcome. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Within 24 hours before hospital discharge
Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale)
Euro-Qol 5D-5L questionnaire includes 5 domains and an optic analogue scale from 0 (worse) up to 100 (best). Each domain (mobility, self care, usual activities, pain / discomfort, anxiety / depression) scores from 1(best score) up to 5 (worse score). The total score of all domains ranges from 5 (best score) up to 25 (worse score).The total perceived quality of life will be graded by the patient.
Measured: Within 24 hours before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start20 Mar 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion20 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk for Reintubation PatientsStudies 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
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISCHAKI ELENI, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908658
- Sponsor's protocol ID
- 6345/14-03-2019
- Status last verified
- Feb 2020
- First submitted
- 4 Apr 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data will be available will be available following publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients
- ClinicalTrials.gov ID
- NCT03908658
- Acronym / sponsor ID
- 6345/14-03-2019
- Keywords
- inspiratory muscle training, Nasal High Flow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 9 Apr 2019 (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 purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.
Detailed description
20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.
Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.
A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training and Nasal High Flow | Active comparator | Other: Inspiratory muscle Training and Nasal High FlowInspiratory Muscle Training will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Nasal High Flow will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU |
| Inspiratory Muscle Training and Venturi mask | Active comparator | Device: Inspiratory muscle training and Venturi maskIMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Venturi mask will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >65 years,
- BMI> 35kg/m2,
- weak cough,
- heart (i.e heart failure ) and lung comorbidities (i.e COPD),
- hypercapnia during mechanical ventilation
Key exclusion criteria (5 listed)
- Glasgow Coma scale (GCS)<13,
- pre-existing neuromuscular disease or deformity of Spinal Cord,
- terminal disease
- hemodynamic instability with >0.1μg/kg/min noradrenaline
- patients of immediately need of Non-invasive ventilation after extubation
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 |
|---|---|---|
| Inspiratory muscle Training and Nasal High FlowInspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght | Other | Inspiratory Muscle Training and Nasal High Flow |
| Inspiratory muscle training and Venturi maskInspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation | Device | Inspiratory Muscle Training and Venturi mask |
Primary outcome
Rate of weaning failure
Time frame: 48 hours after extubation
Rate of weaning failure in high-risk for reintubation patients
7 secondary outcomes
Maximal Inspiratory Pressure
Time frame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Maximal Expiratory Pressure
Time frame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
Endurance of respiratory muscles
Time frame: Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge
Muscle strenght
Time frame: Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge
Functional ability
Time frame: Within 24 hours after ICU discharge, within 24 hours before hospital discharge
Short Form 36 Health Survey (SF-36) questionnaire
Time frame: Within 24 hours before hospital discharge
Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale)
Time frame: Within 24 hours before hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Yes. Participants' data will be available will be available following publication
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 Inspiratory muscle Training and Nasal High Flow and Inspiratory muscle training and Venturi mask in people with High-risk for Reintubation Patients and Weaning Outcome, run by Evangelismos Hospital at 1 site in Greece.
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 7 inclusion and 5 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 12 Feb 2020. 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 Greece. 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?
Contact Anna Christakou (+306977370284, achristakou@phed.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weaning failure (time frame: 48 hours after 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 12 Feb 2020.