Respiration, ArtificialNCT03896048
Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure
An observational study of Respiration, Artificial, run by Respinor AS at 1 site in Norway.
Trial summary
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body. MV involves placing a tube into the wind pipe that is attached to a machine (known as a ventilator) which helps the patient breathe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 25 Mar 2019to 13 Oct 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients on mechanical ventilation in the intensive care unit for greater than 24 hours and who are considered by the treating physician to be eligible for a 30-minute spontaneous breathing trial (SBT).
Who may be able to join
- Older than 17 years,
- At least 24 hours and maximum of 7 days of invasive controlled mechanical ventilation prior to commencing pressure support ventilation,
- A minimum 30-minute SBT is planned to be initiated by the ICU physicians in charge on or before the 14th day of MV, before extubation is considered,
- The reason for admission to the ICU is adequately treated and the general condition is steadily improving, defined as reduction of general supportive ICU therapy, e.g. fluid supplements, cardiovascular stabilising medications, sedative agents, oxygen supply below 50% and mechanical ventilator support,
- Informed consent to participate in the study from patient or the close relative/next to kin.
Who cannot join
- Central or spinal neurological injury influencing central ventilation or its transmission, including critical illness neuropathy and myopathy,
- Diagnosed chronic neuromuscular disease prior to admission,
- Administration of neuromuscular blocking agents within the previous 24 hours,
- Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome >2.5 cm compared to the contralateral dome,
- Patient with therapeutic limitation, i.e. reduced expectancy to survive,
- Women known to be pregnant,
- Protected adult who is not legally responsible and has a legal guardian,
- Skin damage or dressing at the subcostal area at the site of the probe placement.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body. MV involves placing a tube into the wind pipe that is attached to a machine (known as a ventilator) which helps the patient breathe. However, MV is associated with complications such as shrinkage and damage of the diaphragm muscle fibres. It has been shown that the diaphragm (the main breathing muscle which provides approximately 70% of the work in healthy persons) can be affected after only 3-4 days of MV. Disconnection from the ventilator (a process known as extubation) is conducted with the calculated risk that the patient may become exhausted due to the additional workload of breathing off the ventilator resulting in needing to be reconnected to the ventilator (a process known as reintubation). Reintubation requires additional deep sedation of the patient and leads to longer time connected to the ventilator, increased risk of new lung infections, prolonged stay in the intensive care unit (ICU) and further immobilisation. Thus, the intensive care physician must constantly evaluate the need for MV to maintain adequate breathing versus withdrawal as quickly as possible to reduce the risk associated with long-term use of MV. However, to date, there is no technique for continuous assessment of diaphragm function that can be easily used at the patient's bedside. RESPINOR DXT, which offers continuous ultrasound monitoring of the right diaphragm velocity without the need of the continued presence of an operator, could offer an interesting solution.
Aim: The primary objective of this study is to compare diaphragm excursion values obtained around a 30-minute SBT using RESPINOR DXT in patients who are successfully and unsuccessfully extubated. Data analysis will be performed using post-processing. The timepoints to be analysed will be:
Read more
- Pre-SBT: 10, 30 and 60 minutes before the start of the SBT
- During the 30-minute SBT: 0, 1, 2, 3, 4, 10, 20 and 30 minutes
- Post-SBT: 5, 10, 20, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after the end of the 30-minute SBT.
Hypothesis: The investigators hypothesise that there will be significantly different median diaphragm excursion between successful and failed extubation groups in at least one of the timepoints of interest. The information from this pilot study will be used to design a fully-powered observational study.
Primary outcome: Median diaphragm excursion
- Conditions
- Respiration, Artificial
- Keywords
- diaphragm ultrasound, mechanical ventilation, diaphragm function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Successful extubation | Not described | |
| Failed extubation | Failed extubation will be defined as a patient who in the first 48 hours after extubation are reintubated, have unplanned non-invasive ventilation (NIV) or who have a tracheostomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in median diaphragm excursion between patients who are successfully and unsuccessfully extubated
Measured: Up to 48 hours post-extubation
Secondary outcomes (4)
Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully extubated
Measured: Up to 48 hours post-extubation
Thresholds for diaphragm excursion, rapid shallow breathing index (RSBI) and modified RSBI (m-RSBI) to predict extubation or weaning outcome at selected timepoints
Thresholds for continuous diaphragm excursion, RSBI and m-RSBI will be defined by receiver operating characteristic (ROC) curve analysis to predict extubation failure. The sensitivity, specificity, positive and negative predictive value as well as the area under the ROC curves (AUROC) will be presented
Measured: Up to 48 hours post-extubation
Differences in median diaphragm excursion between patients who are successfully and unsuccessfully weaned
Failed weaning will be defined as a patient who fails extubation, fails the SBT or who is not extubated following a successful SBT
Measured: Up to 48 hours post end of SBT
Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully weaned
Measured: Up to 48 hours post end of SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start25 Mar 2019
- Primary completion3 Feb 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respinor AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Daniel Bergum, MD, Principal investigator, St Olav's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896048
- Sponsor's protocol ID
- DM-CS-004
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.
PubMed 15249460Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
PubMed 27677861Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
PubMed 20813887Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
PubMed 21705883Demoule A, Fosse Q, Mercat A, Bergum D, Virolle S, Bureau C, Mellemseter M, Guichou R, Similowski T, Dres M, Mortaza S. Operator independent continuous ultrasound monitoring of diaphragm excursion predicts successful weaning from mechanical ventilation: a prospective observational study. Crit Care. 2024 Jul 16;28(1):245. doi: 10.1186/s13054-024-05003-0.
PubMed 39014512
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure
- ClinicalTrials.gov ID
- NCT03896048
- Acronym / sponsor ID
- DM-CS-004
- Conditions
- Respiration, Artificial
- Keywords
- diaphragm ultrasound, mechanical ventilation, diaphragm function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Respinor ASIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 29 Mar 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.
Background: Patients are put under invasive mechanical ventilation (MV) during respiratory failure because they can no longer breathe in a way that delivers enough oxygen to their body. MV involves placing a tube into the wind pipe that is attached to a machine (known as a ventilator) which helps the patient breathe. However, MV is associated with complications such as shrinkage and damage of the diaphragm muscle fibres. It has been shown that the diaphragm (the main breathing muscle which provides approximately 70% of the work in healthy persons) can be affected after only 3-4 days of MV. Disconnection from the ventilator (a process known as extubation) is conducted with the calculated risk that the patient may become exhausted due to the additional workload of breathing off the ventilator resulting in needing to be reconnected to the ventilator (a process known as reintubation). Reintubation requires additional deep sedation of the patient and leads to longer time connected to the ventilator, increased risk of new lung infections, prolonged stay in the intensive care unit (ICU) and further immobilisation. Thus, the intensive care physician must constantly evaluate the need for MV to maintain adequate breathing versus withdrawal as quickly as possible to reduce the risk associated with long-term use of MV. However, to date, there is no technique for continuous assessment of diaphragm function that can be easily used at the patient's bedside. RESPINOR DXT, which offers continuous ultrasound monitoring of the right diaphragm velocity without the need of the continued presence of an operator, could offer an interesting solution.
Aim: The primary objective of this study is to compare diaphragm excursion values obtained around a 30-minute SBT using RESPINOR DXT in patients who are successfully and unsuccessfully extubated. Data analysis will be performed using post-processing. The timepoints to be analysed will be:
- Pre-SBT: 10, 30 and 60 minutes before the start of the SBT
- During the 30-minute SBT: 0, 1, 2, 3, 4, 10, 20 and 30 minutes
- Post-SBT: 5, 10, 20, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after the end of the 30-minute SBT.
Hypothesis: The investigators hypothesise that there will be significantly different median diaphragm excursion between successful and failed extubation groups in at least one of the timepoints of interest. The information from this pilot study will be used to design a fully-powered observational study.
Primary outcome: Median diaphragm excursion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful extubation | – | – |
| Failed extubation | – | –Failed extubation will be defined as a patient who in the first 48 hours after extubation are reintubated, have unplanned non-invasive ventilation (NIV) or who have a tracheostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients on mechanical ventilation in the intensive care unit for greater than 24 hours and who are considered by the treating physician to be eligible for a 30-minute spontaneous breathing trial (SBT).
Key inclusion criteria (5 listed)
- Older than 17 years,
- At least 24 hours and maximum of 7 days of invasive controlled mechanical ventilation prior to commencing pressure support ventilation,
- A minimum 30-minute SBT is planned to be initiated by the ICU physicians in charge on or before the 14th day of MV, before extubation is considered,
- The reason for admission to the ICU is adequately treated and the general condition is steadily improving, defined as reduction of general supportive ICU therapy, e.g. fluid supplements, cardiovascular stabilising medications, sedative agents, oxygen supply below 50% and mechanical ventilator support,
- Informed consent to participate in the study from patient or the close relative/next to kin.
Key exclusion criteria (8 listed)
- Central or spinal neurological injury influencing central ventilation or its transmission, including critical illness neuropathy and myopathy,
- Diagnosed chronic neuromuscular disease prior to admission,
- Administration of neuromuscular blocking agents within the previous 24 hours,
- Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome >2.5 cm compared to the contralateral dome,
- Patient with therapeutic limitation, i.e. reduced expectancy to survive,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in median diaphragm excursion between patients who are successfully and unsuccessfully extubated
Time frame: Up to 48 hours post-extubation
4 secondary outcomes
Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully extubated
Time frame: Up to 48 hours post-extubation
Thresholds for diaphragm excursion, rapid shallow breathing index (RSBI) and modified RSBI (m-RSBI) to predict extubation or weaning outcome at selected timepoints
Time frame: Up to 48 hours post-extubation
Differences in median diaphragm excursion between patients who are successfully and unsuccessfully weaned
Time frame: Up to 48 hours post end of SBT
Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully weaned
Time frame: Up to 48 hours post end of SBT
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 Jun 2021.
- Background: PubMed 15249460Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.
- Background: PubMed 27677861Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
- Background: PubMed 20813887Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 21705883Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
- Derived from this study: PubMed 39014512Demoule A, Fosse Q, Mercat A, Bergum D, Virolle S, Bureau C, Mellemseter M, Guichou R, Similowski T, Dres M, Mortaza S. Operator independent continuous ultrasound monitoring of diaphragm excursion predicts successful weaning from mechanical ventilation: a prospective observational study. Crit Care. 2024 Jul 16;28(1):245. doi: 10.1186/s13054-024-05003-0.
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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.
Daniel Bergum, MD principal investigator
St Olav's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial, run by Respinor AS at 1 site in Norway.
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 8 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 Jun 2021. 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 Norway. 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?
Differences in median diaphragm excursion between patients who are successfully and unsuccessfully extubated (time frame: Up to 48 hours post-extubation). 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 NCT03896048, which also lists 6 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 14 Jun 2021.