ARDSNCT04435613
Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients
A study testing protective mechanical ventilation strategies in people with ARDS and Volumetric Capnography, run by Clinica las Condes, Chile at 1 site in Chile.
Trial summary
This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Volumetric Capnography
- What is being tested?
- protective mechanical ventilation strategies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 4 Sep 2019to 30 Aug 2020
- 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
- Age older than 18 years
- The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
- Severe hypoxemia (PAFI < 200) secondary to ARDS
Who cannot join
- Heart failure stage IV
- Chronic obstructive pulmonary disease (COPD) on home oxygen
- Bronchopulmonary fistula
- Hypovolemic Shock with active hemorrhage
- Gastrointestinal bleeding
- Oesophageal Varices
Show all 10Show fewer
- Nasopharynx surgery, recent oesophageal or gastric surgery
- Massive Pulmonary Thromboembolism
- Catastrophic respiratory failure requiring urgent extracorporeal life support
- Respiratory acidosis. Hydrogen potential (pH) is less than 7.20 and PaCO2 higher than 60 mmHg at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied
Read the detailed description
Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact.
Baseline:
All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study.
Protocol design:
Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW).
After 30 minutes of continuous monitoring, minute ventilation, mechanical power, variables obtained by volumetric capnography, and arterial blood gases were recorded in each study phase.
This study will be performed in the Intensive Care Unit of a University Hospital.
- Conditions
- ARDS, Volumetric Capnography
- Being tested
- protective mechanical ventilation strategies
- Keywords
- dead space, end-inspiratory pause, respiratory rate, ARDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protective mechanical ventilation strategiesOther
- Reduce tidal volume from 7 ml/kg to 5 ml/kg. 2 Set end-inspiratory pausa. 3 respiratory rate reduction until 20% of the basal condition
| Study group | Role | What they receive |
|---|---|---|
| protective mechanical ventilation | Other | Ten patients with moderate to severe ARDS were subjected to a nearly ultra-protective ventilation strategy generating a reduction in minute ventilation (Tidal volume of 5 ml/kg of predicted body weight together with a 20% reduction in respiratory rate). In addition to end-inspiratory pause, prolongation was set to avoid hypercapnia. Protocol phases: Baseline conditions: Tidal volume of 7 ml/kg. I: Tidal volume of 6 ml/kg. II: Tidal volume of 5 ml/kg. III: Increase end-inspiratory pause until achieving an I:E ratio equal to 1. IV: Respiratory rate reduction until 20% of the basal condition keeping constant I:E ratio equal to 1 Receives: Other: protective mechanical ventilation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome
After the systematic reduction of the tidal volume, end-inspiratory pause prolongation, and the reduction of the respiratory rate, the optimisation of the dead space and the alveolar ventilation could be generated.
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start4 Sep 2019
- Primary completion29 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental, non-randomized study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica las Condes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Benites, Clinica las Condes, Chile
- Investigators
- Martín Benites Albanese, Physician, Principal investigator, Critical Care Department, Clínica Las Condes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435613
- Sponsor's protocol ID
- S022018
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Tusman G, Sipmann FS, Borges JB, Hedenstierna G, Bohm SH. Validation of Bohr dead space measured by volumetric capnography. Intensive Care Med. 2011 May;37(5):870-4. doi: 10.1007/s00134-011-2164-x. Epub 2011 Feb 26.
PubMed 21359609Tusman G, Gogniat E, Bohm SH, Scandurra A, Suarez-Sipmann F, Torroba A, Casella F, Giannasi S, Roman ES. Reference values for volumetric capnography-derived non-invasive parameters in healthy individuals. J Clin Monit Comput. 2013 Jun;27(3):281-8. doi: 10.1007/s10877-013-9433-x. Epub 2013 Feb 7.
PubMed 23389294Lellouche F, Delorme M, Brochard L. Impact of Respiratory Rate and Dead Space in the Current Era of Lung Protective Mechanical Ventilation. Chest. 2020 Jul;158(1):45-47. doi: 10.1016/j.chest.2020.02.033. Epub 2020 Jul 2. No abstract available.
PubMed 32654726Astrom E, Uttman L, Niklason L, Aboab J, Brochard L, Jonson B. Pattern of inspiratory gas delivery affects CO2 elimination in health and after acute lung injury. Intensive Care Med. 2008 Feb;34(2):377-84. doi: 10.1007/s00134-007-0840-7. Epub 2007 Sep 1.
PubMed 17763841Devaquet J, Jonson B, Niklason L, Si Larbi AG, Uttman L, Aboab J, Brochard L. Effects of inspiratory pause on CO2 elimination and arterial PCO2 in acute lung injury. J Appl Physiol (1985). 2008 Dec;105(6):1944-9. doi: 10.1152/japplphysiol.90682.2008. Epub 2008 Sep 18.
PubMed 18801962Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.
PubMed 27558174
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients
- ClinicalTrials.gov ID
- NCT04435613
- Acronym / sponsor ID
- S022018
- Conditions
- ARDS, Volumetric Capnography
- Keywords
- dead space, end-inspiratory pause, respiratory rate, ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clinica las Condes, ChileUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 17 Jun 2020 (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.
This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied
Detailed description
Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact.
Baseline:
All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study.
Protocol design:
Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW).
After 30 minutes of continuous monitoring, minute ventilation, mechanical power, variables obtained by volumetric capnography, and arterial blood gases were recorded in each study phase.
This study will be performed in the Intensive Care Unit of a University Hospital.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| protective mechanical ventilation | Other | Other: protective mechanical ventilation strategiesTen patients with moderate to severe ARDS were subjected to a nearly ultra-protective ventilation strategy generating a reduction in minute ventilation (Tidal volume of 5 ml/kg of predicted body weight together with a 20% reduction in respiratory rate). In addition to end-inspiratory pause, prolongation was set to avoid hypercapnia. Protocol phases: Baseline conditions: Tidal volume of 7 ml/kg. I: Tidal volume of 6 ml/kg. II: Tidal volume of 5 ml/kg. III: Increase end-inspiratory pause until achieving an I:E ratio equal to 1. IV: Respiratory rate reduction until 20% of the basal condition keeping constant I:E ratio equal to 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years
- The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
- Severe hypoxemia (PAFI < 200) secondary to ARDS
Key exclusion criteria (10 listed)
- Heart failure stage IV
- Chronic obstructive pulmonary disease (COPD) on home oxygen
- Bronchopulmonary fistula
- Hypovolemic Shock with active hemorrhage
- Gastrointestinal bleeding
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 |
|---|---|---|
| protective mechanical ventilation strategies1. Reduce tidal volume from 7 ml/kg to 5 ml/kg. 2 Set end-inspiratory pausa. 3 respiratory rate reduction until 20% of the basal condition | Other | protective mechanical ventilation |
Primary outcome
To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome
Time frame: 150 minutes
After the systematic reduction of the tidal volume, end-inspiratory pause prolongation, and the reduction of the respiratory rate, the optimisation of the dead space and the alveolar ventilation could be generated.
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 8 Oct 2021.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 21359609Tusman G, Sipmann FS, Borges JB, Hedenstierna G, Bohm SH. Validation of Bohr dead space measured by volumetric capnography. Intensive Care Med. 2011 May;37(5):870-4. doi: 10.1007/s00134-011-2164-x. Epub 2011 Feb 26.
- Background: PubMed 23389294Tusman G, Gogniat E, Bohm SH, Scandurra A, Suarez-Sipmann F, Torroba A, Casella F, Giannasi S, Roman ES. Reference values for volumetric capnography-derived non-invasive parameters in healthy individuals. J Clin Monit Comput. 2013 Jun;27(3):281-8. doi: 10.1007/s10877-013-9433-x. Epub 2013 Feb 7.
- Background: PubMed 32654726Lellouche F, Delorme M, Brochard L. Impact of Respiratory Rate and Dead Space in the Current Era of Lung Protective Mechanical Ventilation. Chest. 2020 Jul;158(1):45-47. doi: 10.1016/j.chest.2020.02.033. Epub 2020 Jul 2. No abstract available.
- Background: PubMed 17763841Astrom E, Uttman L, Niklason L, Aboab J, Brochard L, Jonson B. Pattern of inspiratory gas delivery affects CO2 elimination in health and after acute lung injury. Intensive Care Med. 2008 Feb;34(2):377-84. doi: 10.1007/s00134-007-0840-7. Epub 2007 Sep 1.
- Background: PubMed 18801962Devaquet J, Jonson B, Niklason L, Si Larbi AG, Uttman L, Aboab J, Brochard L. Effects of inspiratory pause on CO2 elimination and arterial PCO2 in acute lung injury. J Appl Physiol (1985). 2008 Dec;105(6):1944-9. doi: 10.1152/japplphysiol.90682.2008. Epub 2008 Sep 18.
- Background: PubMed 27558174Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.
- Individual participant dataSharing planned: Undecided
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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.
Martín Benites Albanese, Physician principal investigator
Critical Care Department, Clínica Las Condes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protective mechanical ventilation strategies in people with ARDS and Volumetric Capnography, run by Clinica las Condes, Chile at 1 site in Chile.
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 3 inclusion and 10 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome (time frame: 150 minutes). 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 NCT04435613, which also lists 7 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 8 Oct 2021.