Acute Respiratory FailureNCT05378802
Predict Transpulmonary Pressure Through ZAM
A study testing different modes of mechanical ventilation in people with Acute Respiratory Failure, run by Southeast University, China at 1 site in China.
Trial summary
Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi >8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- different modes of mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 10 Aug 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1
Who cannot join
- EAdi<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Spontaneous Breathing and Controlled Ventilation
Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi >8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.
Read the detailed description
- Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM. Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
- Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion. Make record of RR, Vt, Flow, Ti during both periods.
- Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
- Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.
- Conditions
- Acute Respiratory Failure
- Being tested
- different modes of mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different modes of mechanical ventilationOther
Four different ventilation modes were performed one by one and respiratory parameters were recorded.
| Study group | Role | What they receive |
|---|---|---|
| NAVA mode | Experimental | 1. st select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM
2. nd increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase) Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM Receives: Other: different modes of mechanical ventilation |
| N- PSV mode | Experimental | 1. st PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
2. nd increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM Receives: Other: different modes of mechanical ventilation |
| VCV mode | Active comparator | no spontaneous breathing Set Vt, Ti and RR to match the breathing pattern observed during NAVA. Make sure each change in "level" does not increase the pressure by more than 1 cmH2O.
Mode PCV no spontaneous breathing-do ZAM after each PS level Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures. Receives: Other: different modes of mechanical ventilation |
| PCV mode | Active comparator | Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures The idea is not to have pressures as high as 20 cmH2O, it is important to have high enough VCV \& PCV flow rates so we can match the flow rates during spontaneous breathing. You might find that 15 or 16 cmH2O is enough to generate flow rates that match the "maximum" flow rate you saw during spontaneous breathing. Receives: Other: different modes of mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted transpulmonary pressure
Transpulmonary pressure calculated from airway pressure by Prediction formula
Measured: 6 hours
Secondary outcomes (2)
patient-ventilator breath contribution
An index for quantifying the respective patient and ventilator breath contributions
Measured: 6 hours
inspiratory flow
the inspiratory flow measured by the ventilator
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Nov 2021
- Primary completion1 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Haibo Qiu, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378802
- Sponsor's protocol ID
- ZAM study
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a physiological study, we do not intend to disclose the data
Publications
Liu L, He H, Liang M, Beck J, Sinderby C. Estimation of transpulmonary driving pressure using a lower assist maneuver (LAM) during synchronized ventilation in patients with acute respiratory failure: a physiological study. Intensive Care Med Exp. 2024 Oct 4;12(1):89. doi: 10.1186/s40635-024-00674-z.
PubMed 39365383
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spontaneous Breathing and Controlled Ventilation
- ClinicalTrials.gov ID
- NCT05378802
- Acronym / sponsor ID
- ZAM study
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 18 May 2022 (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.
Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi >8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.
Detailed description
- Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM. Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
- Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion. Make record of RR, Vt, Flow, Ti during both periods.
- Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
- Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAVA mode | Experimental | Other: different modes of mechanical ventilation1. st select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM 2. nd increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase) Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM |
| N- PSV mode | Experimental | Other: different modes of mechanical ventilation1. st PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion. 2. nd increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM |
| VCV mode | Active comparator | Other: different modes of mechanical ventilationno spontaneous breathing Set Vt, Ti and RR to match the breathing pattern observed during NAVA. Make sure each change in "level" does not increase the pressure by more than 1 cmH2O. Mode PCV no spontaneous breathing-do ZAM after each PS level Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures. |
| PCV mode | Active comparator | Other: different modes of mechanical ventilationIncrease PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures The idea is not to have pressures as high as 20 cmH2O, it is important to have high enough VCV \& PCV flow rates so we can match the flow rates during spontaneous breathing. You might find that 15 or 16 cmH2O is enough to generate flow rates that match the "maximum" flow rate you saw during spontaneous breathing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1
Key exclusion criteria (1 listed)
- EAdi<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study
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 |
|---|---|---|
| different modes of mechanical ventilationFour different ventilation modes were performed one by one and respiratory parameters were recorded. | Other | N- PSV mode, NAVA mode, PCV mode, VCV mode |
Primary outcome
Predicted transpulmonary pressure
Time frame: 6 hours
Transpulmonary pressure calculated from airway pressure by Prediction formula
2 secondary outcomes
patient-ventilator breath contribution
Time frame: 6 hours
inspiratory flow
Time frame: 6 hours
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 Aug 2023.
- Derived from this study: PubMed 39365383Liu L, He H, Liang M, Beck J, Sinderby C. Estimation of transpulmonary driving pressure using a lower assist maneuver (LAM) during synchronized ventilation in patients with acute respiratory failure: a physiological study. Intensive Care Med Exp. 2024 Oct 4;12(1):89. doi: 10.1186/s40635-024-00674-z.
- Individual participant dataSharing planned: No. This is a physiological study, we do not intend to disclose the data
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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.
Haibo Qiu principal investigator
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different modes of mechanical ventilation in people with Acute Respiratory Failure, run by Southeast University, China at 1 site in China.
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 1 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 Aug 2023. 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 China. 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?
Predicted transpulmonary pressure (time frame: 6 hours). 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 NCT05378802, which also lists 1 linked publication.
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 Aug 2023.