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| Name | Class |
|---|---|
| Fondazione IRCCS San Gerardo dei Tintori | OTHER |
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The goal of this physiological study is to determine whether ventilator-delivered sigh breaths during pressure support ventilation (PSV) provide a reliable bedside index of lung recruitability and can guide PEEP optimization.The main questions it aims to answer are:
Background and RationaleInvasive mechanical ventilation is often necessary in critically ill adults but may contribute to ventilator-induced lung injury (VILI) if ventilator settings are not individualized. During assisted ventilation (pressure support ventilation, PSV), ongoing patient effort complicates the assessment of PEEP response, PEEP titration, and lung recruitability.Ventilator-delivered sigh breaths (i.e., brief sustained inflations) can improve gas exchange and promote alveolar recruitment, and may permit artifact-free assessment of respiratory mechanics in assisted modes. This study evaluates whether Crs measured at the end of a sigh provides reliable, clinically useful information on recruitability and whether the ratio of Crs during sigh to Crs during an assisted breath (Crs_sigh/Crs_assisted) can guide positive end-expiratory pressure (PEEP) optimization.Primary ObjectiveTo assess lung recruitability during PSV by normalizing Crs measured at the end of a sigh to Crs obtained with an inspiratory hold during an assisted breath.Secondary Objectives
Inclusion criteria:Adults (≥18 years) receiving PSV with the ventilator's sigh function active.Exclusion criteria:
Protocol OverviewEach participant undergoes two sequential, non-randomized steps:
In both steps, a sigh is programmed as a sustained inflation at 30 cmH₂O for 3 seconds (pressure-controlled), per routine practice and prior literature.Sigh Setting
Data CollectionBaseline demographics (age, sex, BMI), comorbidities, and hemodynamics are recorded. At the end of each 15-minute step (baseline and PEEP+3), we perform an end-inspiratory hold and an end-expiratory hold on a tidal assisted breath and measured:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical PEEP (baseline) | Experimental | Pressure support ventilation (PSV) at the clinical PEEP with ventilator-delivered sighs: one sustained inflation at 30 cmH₂O for 3 seconds every minute. |
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| Clinical PEEP +3 cmH₂O | Experimental | Pressure support ventilation (PSV) with PEEP set 3 cmH₂O above the clinical PEEP, with ventilator-delivered sighs: one sustained inflation at 30 cmH₂O for 3 seconds every minute. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) | Other | Each patient undergoes two sequential 15-minute steps: 1) pressure support ventilation at the clinical PEEP and 2) the same settings with PEEP increased by 3 cmH₂O. A ventilator-delivered sigh is programmed as one sustained inflation at 30 cmH₂O for 3 seconds every minute. All other ventilator parameters (trigger sensitivity, pressure support level, mandatory breath timing) remain unchanged. At the end of each step, inspiratory and expiratory holds are performed to collect respiratory mechanics and arterial blood gases; compliance during the sigh is calculated once flow is zero and airway pressure is stable. |
| Measure | Description | Time Frame |
|---|---|---|
| Sigh-to-Assisted Breath Respiratory System Compliance Ratio (Crs_sigh/Crs_assisted) | Ratio of respiratory system compliance at the end of a ventilator-delivered sigh to compliance measured during an inspiratory hold on an assisted tidal breath. This normalized metric indexes recruitability during assisted ventilation; higher values indicate greater recruitability. The primary analysis is the within-patient change in the ratio from clinical PEEP to clinical PEEP +3 cmH₂O. | End of each 15-minute step within a single study session (clinical PEEP; clinical PEEP +3 cmH₂O). |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with unreliable plateau pressure during assisted breaths | Proportion of patients in whom Pplat cannot be reliably measured (non-readable or visually unstable for ≥3 seconds) during inspiratory hold maneuvers in assisted breathing at either study step. | Across both 15-minute steps within the single study session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maurizio Bufalini | Cesena | Italy | 47521 | Italy | ||
| Fondazione IRCCS San Gerardo dei Tintori |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23344834 | Background | Shehabi Y, Chan L, Kadiman S, Alias A, Ismail WN, Tan MA, Khoo TM, Ali SB, Saman MA, Shaltut A, Tan CC, Yong CY, Bailey M; Sedation Practice in Intensive Care Evaluation (SPICE) Study Group investigators. Sedation depth and long-term mortality in mechanically ventilated critically ill adults: a prospective longitudinal multicentre cohort study. Intensive Care Med. 2013 May;39(5):910-8. doi: 10.1007/s00134-013-2830-2. Epub 2013 Jan 24. | |
| 30790029 |
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Data may be shared after reasonable request to the Principal investigator.
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|
| Association between sigh-derived recruitability index and change in respiratory system compliance |
Correlation between the sigh-to-assisted compliance ratio at clinical PEEP and the within-patient change in compliance after PEEP increase |
| End of each 15-minute step within the single study session |
| Monza |
| Italy |
| 29000 |
| Italy |
| Background |
| Marin-Corral J, Dot I, Boguna M, Cecchini L, Zapatero A, Gracia MP, Pascual-Guardia S, Vila C, Castellvi A, Perez-Teran P, Gea J, Masclans JR. Structural differences in the diaphragm of patients following controlled vs assisted and spontaneous mechanical ventilation. Intensive Care Med. 2019 Apr;45(4):488-500. doi: 10.1007/s00134-019-05566-5. Epub 2019 Feb 21. |
| 34952477 | Background | Bianchi I, Grassi A, Pham T, Telias I, Teggia Droghi M, Vieira F, Jonkman A, Brochard L, Bellani G. Reliability of plateau pressure during patient-triggered assisted ventilation. Analysis of a multicentre database. J Crit Care. 2022 Apr;68:96-103. doi: 10.1016/j.jcrc.2021.12.002. Epub 2021 Dec 21. |
| 37326475 | Background | Bastia L, Amendolagine L, Pozzi F, Carenini S, Cipolla C, Curto F, Bellani G, Fumagalli R, Chieregato A. Reliability of Respiratory System Compliance Calculation During Assisted Mechanical Ventilation: A Retrospective Study. Crit Care Med. 2023 Oct 1;51(10):e201-e205. doi: 10.1097/CCM.0000000000005964. Epub 2023 Jun 16. |
| 39527121 | Background | Mauri T, Grieco DL, Spinelli E, Leali M, Perez J, Chiavieri V, Rosa T, Ferrara P, Scaramuzzo G, Antonelli M, Spadaro S, Grasselli G. Personalized positive end-expiratory pressure in spontaneously breathing patients with acute respiratory distress syndrome by simultaneous electrical impedance tomography and transpulmonary pressure monitoring: a randomized crossover trial. Intensive Care Med. 2024 Dec;50(12):2125-2137. doi: 10.1007/s00134-024-07695-y. Epub 2024 Nov 11. |
| 35499759 | Background | Jonkman AH, Ranieri VM, Brochard L. Lung recruitment. Intensive Care Med. 2022 Jul;48(7):936-938. doi: 10.1007/s00134-022-06715-z. Epub 2022 May 2. No abstract available. |
| 25113136 | Background | Moraes L, Santos CL, Santos RS, Cruz FF, Saddy F, Morales MM, Capelozzi VL, Silva PL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Effects of sigh during pressure control and pressure support ventilation in pulmonary and extrapulmonary mild acute lung injury. Crit Care. 2014 Aug 12;18(4):474. doi: 10.1186/s13054-014-0474-4. |
| 11964584 | Background | Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94. doi: 10.1097/00000542-200204000-00004. |
| 37877609 | Background | Albert RK, Jurkovich GJ, Connett J, Helgeson ES, Keniston A, Voelker H, Lindberg S, Proper JL, Bochicchio G, Stein DM, Cain C, Tesoriero R, Brown CVR, Davis J, Napolitano L, Carver T, Cipolle M, Cardenas L, Minei J, Nirula R, Doucet J, Miller PR, Johnson J, Inaba K, Kao L. Sigh Ventilation in Patients With Trauma: The SiVent Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1982-1990. doi: 10.1001/jama.2023.21739. |
| 25985386 | Background | Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083. |