Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure

NCT03896048 | Completed

• 1 other identifier: DM-CS-004
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Respiration, Artificial

Keywords

diaphragm ultrasound; mechanical ventilation; diaphragm function

Outcome Measures

Primary Outcomes (1)

• Differences in median diaphragm excursion between patients who are successfully and unsuccessfully extubated

  Up to 48 hours post-extubation

Secondary Outcomes (4)

• 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

  Up to 48 hours post-extubation

• Differences in median diaphragm excursion between patients who are successfully and unsuccessfully weaned

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Respinor AS: lead
• European Commission: collaborator

Study Sites (1)

St Olav's Hospital

Trondheim, Norway

Location

Related Publications (6)

• 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.

  PMID: 15249460 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.

  PMID: 27677861 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.

  PMID: 20813887 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.

  PMID: 18367735 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.

  PMID: 21705883 BACKGROUND

• 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.

  PMID: 39014512 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Bergum, MD

  St Olav's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: March 25, 2019
• Primary Completion: February 3, 2020
• Study Completion: October 13, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

NO (1)