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| Name | Class |
|---|---|
| European Commission | OTHER |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in median diaphragm excursion between patients who are successfully and unsuccessfully extubated | Up to 48 hours post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully extubated | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Bergum, MD | St Olav's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olav's Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15249460 | Background | 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. | |
| 27677861 | Background | Spadaro 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. |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
| 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 | Up to 48 hours post end of SBT |
| Differences in maximum diaphragm excursion between patients who are successfully and unsuccessfully weaned | Up to 48 hours post end of SBT |
| 20813887 | Background | Jaber 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. |
| 18367735 | Background | Levine 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. |
| 21705883 | Background | Kim 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. |
| 39014512 | Derived | Demoule 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. |