Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies

NCT05144607 | Completed

• 1 other identifier: AVAP-NG 2219
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-ventilator asynchronies can occur as a result of a mismatch between neural (patient) and ventilator inspiratory and expiratory phases. Sensitivity of this visual analysis, even when performed by experts in the field, is low, around 28% in one landmark publication. The impact of the display of Pmus together with the other ventilator waveforms on the ability of health-care professionals to identify asynchronies has not been tested so far. OBJECTIVES: To compare the sensitivity and specificity of the detection of patient-ventilator asynchrony by health professionals through visual inspection of the ventilator waveforms (conventional group) with the sensitivity and specificity of health professionals who have available, in addition to these ventilator waveforms, also the estimated inspiratory muscle pressure curve (Pmus group). METHODS: Participants will analyze 49 consecutive different scenarios of mechanical ventilation generated in a simulator. Intensive care unit physicians and respiratory therapist will be invited to participate and after the inclusion will be randomized to one of two groups: 1) the control group will inspect pressure and flow curves and 2) the Pmus group will inspect pressure, flow, and Pmus curves. Before the start of the study, all participants will have a 30-min training session to homogenize their concepts on the definitions of the different types of asynchrony. Subsequently, the participants will be randomized to the conventional group or Pmus group. Participants will be designated to watch different sessions, in groups of at most 20 individuals, according to their randomization. In these sessions, recorded ventilator waveforms will be projected to a large screen for 30 seconds. A still image containing a few ventilatory cycles will remain visible for another 30 seconds when participants will have to choose which asynchrony (if any) the participants can see on the screen. Sessions of the Pmus group will display, in addition to pressure and flow, the estimated muscle pressure curves. The main outcome is the asynchrony detection rate (sensitivity). It will be also compared specificity, positive and negative predictive values for asynchrony detection. Statistical significance will be set at an alpha level of 0.05. The sample size was estimated in 98 participants based on the expectation of a 10 percentage points difference in the sensitivity between groups.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Ability of ICU health care professionals to detect patient-ventilator asynchrony

  The mean sensitivity to detect asynchronies, calculated for each healthcare professional, will be compared between the groups.

  Immediately after the completion of the test sessions

Secondary Outcomes (1)

• Other measures of diagnostic ability

  Immediately after the completion of the test sessions

Study Arms (2)

Control group

NO INTERVENTION

Detection of patient-ventilator asynchronies through visual inspection of pressure and flow waveforms.

Pmus group

EXPERIMENTAL

Detection of patient-ventilator asynchronies through visual inspection of estimated inspiratory muscle pressure curves, in addition to pressure and flow waveforms.

Other: Muscle Pressure curve (Pmus)

Interventions

Muscle Pressure curve (Pmus) OTHER

The intervention will be the display of an additional curve - the estimated inspiratory muscle pressure waveform generated using an artificial intelligence algorithm.

Pmus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare professionals (physicians and respiratory therapists) who work in intensive care units

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sirio Libanes

São Paulo, 01308-000, Brazil

Location

Related Publications (33)

• Kondili E, Prinianakis G, Alexopoulou C, Vakouti E, Klimathianaki M, Georgopoulos D. Respiratory load compensation during mechanical ventilation--proportional assist ventilation with load-adjustable gain factors versus pressure support. Intensive Care Med. 2006 May;32(5):692-9. doi: 10.1007/s00134-006-0110-0. Epub 2006 Mar 8.

  PMID: 16523329 BACKGROUND

• Tobin MJ, Laghi F, Jubran A. Narrative review: ventilator-induced respiratory muscle weakness. Ann Intern Med. 2010 Aug 17;153(4):240-5. doi: 10.7326/0003-4819-153-4-201008170-00006.

  PMID: 20713792 BACKGROUND

• Powers SK, Kavazis AN, Levine S. Prolonged mechanical ventilation alters diaphragmatic structure and function. Crit Care Med. 2009 Oct;37(10 Suppl):S347-53. doi: 10.1097/CCM.0b013e3181b6e760.

  PMID: 20046120 BACKGROUND

• Jubran A. Critical illness and mechanical ventilation: effects on the diaphragm. Respir Care. 2006 Sep;51(9):1054-61; discussion 1062-4.

  PMID: 16934168 BACKGROUND

• Laghi F, Tobin MJ. Disorders of the respiratory muscles. Am J Respir Crit Care Med. 2003 Jul 1;168(1):10-48. doi: 10.1164/rccm.2206020.

  PMID: 12826594 BACKGROUND

• Vassilakopoulos T, Petrof BJ. Ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Feb 1;169(3):336-41. doi: 10.1164/rccm.200304-489CP. No abstract available.

  PMID: 14739134 BACKGROUND

• Goligher EC, Brochard LJ, Reid WD, Fan E, Saarela O, Slutsky AS, Kavanagh BP, Rubenfeld GD, Ferguson ND. Diaphragmatic myotrauma: a mediator of prolonged ventilation and poor patient outcomes in acute respiratory failure. Lancet Respir Med. 2019 Jan;7(1):90-98. doi: 10.1016/S2213-2600(18)30366-7. Epub 2018 Nov 16.

  PMID: 30455078 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

• Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.

  PMID: 27492005 BACKGROUND

• Dres M, Rittayamai N, Brochard L. Monitoring patient-ventilator asynchrony. Curr Opin Crit Care. 2016 Jun;22(3):246-53. doi: 10.1097/MCC.0000000000000307.

  PMID: 27070802 BACKGROUND

• Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.

  PMID: 16896854 BACKGROUND

• Nava S, Bruschi C, Fracchia C, Braschi A, Rubini F. Patient-ventilator interaction and inspiratory effort during pressure support ventilation in patients with different pathologies. Eur Respir J. 1997 Jan;10(1):177-83. doi: 10.1183/09031936.97.10010177.

  PMID: 9032512 BACKGROUND

• Pohlman MC, McCallister KE, Schweickert WD, Pohlman AS, Nigos CP, Krishnan JA, Charbeneau JT, Gehlbach BK, Kress JP, Hall JB. Excessive tidal volume from breath stacking during lung-protective ventilation for acute lung injury. Crit Care Med. 2008 Nov;36(11):3019-23. doi: 10.1097/CCM.0b013e31818b308b.

  PMID: 18824913 BACKGROUND

• Pham T, Telias I, Piraino T, Yoshida T, Brochard LJ. Asynchrony Consequences and Management. Crit Care Clin. 2018 Jul;34(3):325-341. doi: 10.1016/j.ccc.2018.03.008.

  PMID: 29907268 BACKGROUND

• Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.

  PMID: 33381233 BACKGROUND

• Mellott KG, Grap MJ, Munro CL, Sessler CN, Wetzel PA, Nilsestuen JO, Ketchum JM. Patient ventilator asynchrony in critically ill adults: frequency and types. Heart Lung. 2014 May-Jun;43(3):231-43. doi: 10.1016/j.hrtlng.2014.02.002.

  PMID: 24794784 BACKGROUND

• Fabry B, Guttmann J, Eberhard L, Bauer T, Haberthur C, Wolff G. An analysis of desynchronization between the spontaneously breathing patient and ventilator during inspiratory pressure support. Chest. 1995 May;107(5):1387-94. doi: 10.1378/chest.107.5.1387.

  PMID: 7750336 BACKGROUND

• Holanda MA, Vasconcelos RDS, Ferreira JC, Pinheiro BV. Patient-ventilator asynchrony. J Bras Pneumol. 2018 Jul-Aug;44(4):321-333. doi: 10.1590/S1806-37562017000000185. Epub 2018 Jul 6.

  PMID: 30020347 BACKGROUND

• Murias G, Lucangelo U, Blanch L. Patient-ventilator asynchrony. Curr Opin Crit Care. 2016 Feb;22(1):53-9. doi: 10.1097/MCC.0000000000000270.

  PMID: 26627539 BACKGROUND

• Colombo D, Cammarota G, Alemani M, Carenzo L, Barra FL, Vaschetto R, Slutsky AS, Della Corte F, Navalesi P. Efficacy of ventilator waveforms observation in detecting patient-ventilator asynchrony. Crit Care Med. 2011 Nov;39(11):2452-7. doi: 10.1097/CCM.0b013e318225753c.

  PMID: 21705886 BACKGROUND

• Gilstrap D, MacIntyre N. Patient-ventilator interactions. Implications for clinical management. Am J Respir Crit Care Med. 2013 Nov 1;188(9):1058-68. doi: 10.1164/rccm.201212-2214CI.

  PMID: 24070493 BACKGROUND

• Chatburn RL, Mireles-Cabodevila E. 2019 Year in Review: Patient-Ventilator Synchrony. Respir Care. 2020 Apr;65(4):558-572. doi: 10.4187/respcare.07635.

  PMID: 32213603 BACKGROUND

• Schreiber A, Bertoni M, Goligher EC. Avoiding Respiratory and Peripheral Muscle Injury During Mechanical Ventilation: Diaphragm-Protective Ventilation and Early Mobilization. Crit Care Clin. 2018 Jul;34(3):357-381. doi: 10.1016/j.ccc.2018.03.005.

  PMID: 29907270 BACKGROUND

• Sinderby C, Liu S, Colombo D, Camarotta G, Slutsky AS, Navalesi P, Beck J. An automated and standardized neural index to quantify patient-ventilator interaction. Crit Care. 2013 Oct 16;17(5):R239. doi: 10.1186/cc13063.

  PMID: 24131701 BACKGROUND

• Chappell HW. Nurses' commitment makes a difference in discharge planning. Interview by Nancy Prewitt. Ky Nurse. 1989 May-Jun;37(3):13-4. No abstract available.

  PMID: 2733426 BACKGROUND

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

  PMID: 24467647 BACKGROUND

• de Wit M, Miller KB, Green DA, Ostman HE, Gennings C, Epstein SK. Ineffective triggering predicts increased duration of mechanical ventilation. Crit Care Med. 2009 Oct;37(10):2740-5. doi: 10.1097/ccm.0b013e3181a98a05.

  PMID: 19886000 BACKGROUND

• Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.

  PMID: 25693449 BACKGROUND

• Blanch L, Sales B, Montanya J, Lucangelo U, Garcia-Esquirol O, Villagra A, Chacon E, Estruga A, Borelli M, Burgueno MJ, Oliva JC, Fernandez R, Villar J, Kacmarek R, Murias G. Validation of the Better Care(R) system to detect ineffective efforts during expiration in mechanically ventilated patients: a pilot study. Intensive Care Med. 2012 May;38(5):772-80. doi: 10.1007/s00134-012-2493-4. Erratum In: Intensive Care Med. 2013 Feb;39(2):341.

  PMID: 22297667 BACKGROUND

• Kondili E, Prinianakis G, Georgopoulos D. Patient-ventilator interaction. Br J Anaesth. 2003 Jul;91(1):106-19. doi: 10.1093/bja/aeg129. No abstract available.

  PMID: 12821570 BACKGROUND

• Ramirez II, Arellano DH, Adasme RS, Landeros JM, Salinas FA, Vargas AG, Vasquez FJ, Lobos IA, Oyarzun ML, Restrepo RD. Ability of ICU Health-Care Professionals to Identify Patient-Ventilator Asynchrony Using Waveform Analysis. Respir Care. 2017 Feb;62(2):144-149. doi: 10.4187/respcare.04750. Epub 2016 Oct 25.

  PMID: 28108684 BACKGROUND

• Parthasarathy S, Jubran A, Tobin MJ. Assessment of neural inspiratory time in ventilator-supported patients. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):546-52. doi: 10.1164/ajrccm.162.2.9901024.

  PMID: 10934085 BACKGROUND

• Bellani G, Mauri T, Coppadoro A, Grasselli G, Patroniti N, Spadaro S, Sala V, Foti G, Pesenti A. Estimation of patient's inspiratory effort from the electrical activity of the diaphragm. Crit Care Med. 2013 Jun;41(6):1483-91. doi: 10.1097/CCM.0b013e31827caba0.

  PMID: 23478659 BACKGROUND

Study Officials

• Eduardo LV Costa

  Hospital Sirio-Libanes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two groups: control group or Pmus group. The control group will watch recorded ventilator waveforms (pressure and flow), and the Pmus group will watch, in addition to pressure and flow, estimated muscle pressure curves based on artificial intelligence. For each of 49 scenarios recorded from simulated conditions using the ASL-5000 simulator, participants will have to select among multiple choices if there was patient-ventilator asynchrony.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 3, 2021
• Study Start: September 24, 2021
• Primary Completion: September 29, 2021
• Study Completion: October 6, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

BR (1)