Mechanical VentilationNCT07172061
Sigh in Pressure Support Ventilation to Detect Respiratory System Compliance and Lung Recruitability
A study testing PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) in people with Mechanical Ventilation, run by AUSL Romagna Rimini at 2 sites in Italy.
Trial summary
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: Does respiratory system compliance measured at the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) receiving PSV with the ventilator's sigh function active.
Who cannot join
- Clinical contraindication to increasing PEEP
- Hemodynamic instability defined as SOFA cardiovascular score ≥3
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Maurizio Bufalini
Cesena, Italy, 47521
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 29000
About this study
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:
- Does respiratory system compliance measured at the end of a sigh (Crs_sigh) differ from compliance obtained with an inspiratory hold during an assisted breath (Crs_assisted), and can the Crs_sigh/Crs_assisted ratio indicate recruitability?
- Does adjusting PEEP based on the sigh-derived recruitability index improve respiratory mechanics and gas exchange compared with usual clinical PEEP settings?
Read the detailed description
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
- To quantify the proportion of patients in whom Pplat during assisted breathing is not reliable (non-readable or unstable ≥3 s).
- To determine whether adjusting PEEP according to the sigh-derived recruitability index improves Crs.
Inclusion criteria:Adults (≥18 years) receiving PSV with the ventilator's sigh function active.Exclusion criteria:
- Clinical contraindication to increasing PEEP
- Hemodynamic instability defined as SOFA cardiovascular score ≥3
Protocol OverviewEach participant undergoes two sequential, non-randomized steps:
- Step 1 (Clinical PEEP): Measurements are performed after ≥15 minutes at the treating team's current PEEP.
- Step 2 (Clinical PEEP +3 cmH₂O): PEEP is increased by 3 cmH₂O; measurements are repeated after ≥15 minutes of stabilization.
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
- Sigh frequency: 1 sustained inflation every minute.
- Sigh target: 30 cmH₂O for 3 seconds.
- If end-inspiratory flow did not reach 0 L/min, the inspiratory time of the sigh was extended to ensure an end-inspiratory alveolar pressure of 30 cmH₂O.
- The sigh pressure was identical in both PEEP steps.
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:
- Plateau pressure (Pplat): Pplat is considered reliable only if the pressure trace is visually stable (flat) during the inspiratory hold.
- Static driving pressure: DP_st = Pplat - PEEP.
- Dynamic driving pressure: DP_dyn = Pressure Support + (ΔP_occ × 0.75), where ΔP_occ is the difference between total PEEP and the low airway pressure during the expiratory-hold maneuver.
- Tidal volume (Vt).
- Respiratory system compliance on tidal assisted breath: Crs_tidal = Vt / DP_st.
- P0.1.
- Occlusion pressure (P_occ).
- Pressure Muscle Index: PMI = P_peak - Pplat.
- Ventilatory Ratio (VR).
- Arterial blood gas (ABG). Compliance During Sigh and S/T IndexCrs during the mandatory sigh (Crs_sigh) is computed at each step using the sigh volume and pressure recorded once the inspiratory flow reaches 0 L/min and airway pressure (Paw) is visually stable.The S/T index is defined as the ratio Crs_sigh / Crs_tidal.Using baseline Crs_tidal, we estimate the sigh-induced volume (mL):V_sigh,expected = (Psigh_peak - PEEP) × Crs_tidal,baseline.We also derive a compliance valid for the pressure range above Pplat up to the sigh pressure ("over-plateau" compliance):Crs_overplat = (Vt_sigh - Vt_tidal) / (Psigh - Pplat).
- Conditions
- Mechanical Ventilation
- Being tested
- PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)
- Keywords
- Assisted ventilation, Pressure support ventilation (PSV), PEEP, Recruitment, Sigh, Respiratory system compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) |
| 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. Receives: Other: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of each 15-minute step within a single study session (clinical PEEP; clinical PEEP +3 cmH₂O).
Secondary outcomes (2)
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.
Measured: Across both 15-minute steps within the single study session.
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
Measured: End of each 15-minute step within the single study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Jul 2024
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS San Gerardo dei Tintori
- Responsible party
- Principal investigator, Luca Bastia, AUSL Romagna Rimini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172061
- Sponsor's protocol ID
- SIREC
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared after reasonable request to the Principal investigator.
Publications
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.
PubMed 23344834Marin-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.
PubMed 30790029Bianchi 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.
PubMed 34952477Bastia 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.
PubMed 37326475Mauri 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.
PubMed 39527121Jonkman 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.
PubMed 35499759Moraes 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.
PubMed 25113136Patroniti 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.
PubMed 11964584Albert 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.
PubMed 37877609Mauri 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.
PubMed 25985386
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sigh in Pressure Support Ventilation to Detect Respiratory System Compliance and Lung Recruitability
- ClinicalTrials.gov ID
- NCT07172061
- Acronym / sponsor ID
- SIREC
- Conditions
- Mechanical Ventilation
- Keywords
- Assisted ventilation, Pressure support ventilation (PSV), PEEP, Recruitment, Sigh, Respiratory system compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Collaborators
- Fondazione IRCCS San Gerardo dei Tintori
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Sep 2025 (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.
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:
- Does respiratory system compliance measured at the end of a sigh (Crs_sigh) differ from compliance obtained with an inspiratory hold during an assisted breath (Crs_assisted), and can the Crs_sigh/Crs_assisted ratio indicate recruitability?
- Does adjusting PEEP based on the sigh-derived recruitability index improve respiratory mechanics and gas exchange compared with usual clinical PEEP settings?
Detailed description
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
- To quantify the proportion of patients in whom Pplat during assisted breathing is not reliable (non-readable or unstable ≥3 s).
- To determine whether adjusting PEEP according to the sigh-derived recruitability index improves Crs.
Inclusion criteria:Adults (≥18 years) receiving PSV with the ventilator's sigh function active.Exclusion criteria:
- Clinical contraindication to increasing PEEP
- Hemodynamic instability defined as SOFA cardiovascular score ≥3
Protocol OverviewEach participant undergoes two sequential, non-randomized steps:
- Step 1 (Clinical PEEP): Measurements are performed after ≥15 minutes at the treating team's current PEEP.
- Step 2 (Clinical PEEP +3 cmH₂O): PEEP is increased by 3 cmH₂O; measurements are repeated after ≥15 minutes of stabilization.
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
- Sigh frequency: 1 sustained inflation every minute.
- Sigh target: 30 cmH₂O for 3 seconds.
- If end-inspiratory flow did not reach 0 L/min, the inspiratory time of the sigh was extended to ensure an end-inspiratory alveolar pressure of 30 cmH₂O.
- The sigh pressure was identical in both PEEP steps.
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:
- Plateau pressure (Pplat): Pplat is considered reliable only if the pressure trace is visually stable (flat) during the inspiratory hold.
- Static driving pressure: DP_st = Pplat - PEEP.
- Dynamic driving pressure: DP_dyn = Pressure Support + (ΔP_occ × 0.75), where ΔP_occ is the difference between total PEEP and the low airway pressure during the expiratory-hold maneuver.
- Tidal volume (Vt).
- Respiratory system compliance on tidal assisted breath: Crs_tidal = Vt / DP_st.
- P0.1.
- Occlusion pressure (P_occ).
- Pressure Muscle Index: PMI = P_peak - Pplat.
- Ventilatory Ratio (VR).
- Arterial blood gas (ABG). Compliance During Sigh and S/T IndexCrs during the mandatory sigh (Crs_sigh) is computed at each step using the sigh volume and pressure recorded once the inspiratory flow reaches 0 L/min and airway pressure (Paw) is visually stable.The S/T index is defined as the ratio Crs_sigh / Crs_tidal.Using baseline Crs_tidal, we estimate the sigh-induced volume (mL):V_sigh,expected = (Psigh_peak - PEEP) × Crs_tidal,baseline.We also derive a compliance valid for the pressure range above Pplat up to the sigh pressure ("over-plateau" compliance):Crs_overplat = (Vt_sigh - Vt_tidal) / (Psigh - Pplat).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical PEEP (baseline) | Experimental | Other: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)Pressure support ventilation (PSV) at the clinical PEEP with ventilator-delivered sighs: one sustained inflation at 30 cmH₂O for 3 seconds every minute. |
| Clinical PEEP +3 cmH₂O | Experimental | Other: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years) receiving PSV with the ventilator's sigh function active.
Key exclusion criteria (2 listed)
- Clinical contraindication to increasing PEEP
- Hemodynamic instability defined as SOFA cardiovascular score ≥3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)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. | Other | Clinical PEEP (baseline), Clinical PEEP +3 cmH₂O |
Primary outcome
Sigh-to-Assisted Breath Respiratory System Compliance Ratio (Crs_sigh/Crs_assisted)
Time frame: End of each 15-minute step within a single study session (clinical PEEP; clinical PEEP +3 cmH₂O).
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.
2 secondary outcomes
Patients with unreliable plateau pressure during assisted breaths
Time frame: Across both 15-minute steps within the single study session.
Association between sigh-derived recruitability index and change in respiratory system compliance
Time frame: End of each 15-minute step within the single study session
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 15 Sep 2025.
- Background: PubMed 23344834Shehabi 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.
- Background: PubMed 30790029Marin-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.
- Background: PubMed 34952477Bianchi 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.
- Background: PubMed 37326475Bastia 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.
- Background: PubMed 39527121Mauri 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.
- Background: PubMed 35499759Jonkman 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.
- Background: PubMed 25113136Moraes 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.
- Background: PubMed 11964584Patroniti 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.
- Background: PubMed 37877609Albert 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.
- Background: PubMed 25985386Mauri 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.
- Individual participant dataSharing planned: No. Data may be shared after reasonable request to the Principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) in people with Mechanical Ventilation, run by AUSL Romagna Rimini at 2 sites in Italy.
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 1 inclusion and 2 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Sigh-to-Assisted Breath Respiratory System Compliance Ratio (Crs_sigh/Crs_assisted) (time frame: End of each 15-minute step within a single study session (clinical PEEP; clinical PEEP +3 cmH₂O).). 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 NCT07172061, which also lists 10 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 15 Sep 2025.