COPD (Chronic Obstructive Pulmonary Disease)PYENCT07207967
End-Inspiratory Pause in COPD Patients During Controlled Ventilation
A study testing NO PAUSE VENTILATION in people with COPD (Chronic Obstructive Pulmonary Disease), run by Sanatorio Anchorena San Martin at 1 site in Argentina.
Trial summary
In patients with airflow obstruction receiving mechanical ventilation, an important objective is to reduce lung hyperinflation often using controlled hypoventilation. At the same time, maintaining acceptable gas exchange is challenging, as major reductions in minute ventilation (VE) raises carbon dioxide (CO2) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- NO PAUSE VENTILATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2024to 1 Sep 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
- deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort
- sign the informed consent
Who cannot join
- Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Sanatorio Anchorena San Martín
San Martín, Buenos Aires, B1650
About this study
Official title: End-Inspiratory Pause Enhances Ventilation Efficiency Without Affecting autoPEEP in COPD Patients During Controlled Ventilation
In patients with airflow obstruction receiving mechanical ventilation, an important objective is to reduce lung hyperinflation often using controlled hypoventilation. At the same time, maintaining acceptable gas exchange is challenging, as major reductions in minute ventilation (VE) raises carbon dioxide (CO2) and causes respiratory acidosis, which may lead to adverse physiological consequences.
Relatively prolonged end-inspiratory pause (EIP) has been shown to optimize CO2 clearance in hypoxemic mechanically ventilated patients. Previous data suggests that, at equivalent total inspiratory-time (TI), shorter insufflations followed by EIP can enhance CO2 elimination in acute lung injury. Adding EIP is classically discouraged in chronic obstructive pulmonary disease (COPD) because - at constant respiratory rate (RR) - prolonging inspiration reduces expiratory time (TE), and can worsen hyperinflation and impair hemodynamics.
Read more
In this study, we assessed whether a breathing pattern characterized by high inspiratory flow (V ̇) plus EIP could reduce PaCO2 without inducing hyperinflation, compared with same inspiration-to-expiration time (I:E) and a ventilation pattern without EIP in patients with COPD undergoing controlled hypoventilation.
Methods We performed a prospective, single-center, cross-over, randomized trial (ethical approval #10/2024) including deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort. Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria. Patient's next of kin signed the informed consent.
At inclusion, we collected demographic characteristics and baseline respiratory variables. A CT-emphysema score, using computed tomographies obtained within 24 hs of intubation for clinical reasons, was calculated (A.R, a pulmonologist specialized in medical imaging). Each lung was divided into 3 regions (superior, medium and inferior) based on anatomical references and were graded as no emphysema (score 0), emphysema ≤25% (score 1), ≤50% (score 2), ≤75% (score 3) and >75% (score 4). Scores of the six regions were summed to obtain the total score, giving a minimum 0 and a maximum of 24 points. Total scores ≥ 2 are indicative of emphysema.
Patients were ventilated in volume-controlled mode with square-flow waveform, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) was set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%.
Two ventilation strategies, each one applied for 30 minutes, were randomly evaluated: a) ventilation without EIP, using initial ventilator settings (VentNO-PAUSE); b) ventilation with EIP (VentPAUSE), in which V ̇ was increased and 40-50% of the total inspiratory time (TI) was replaced by EIP; the remaining setting were equal to VentNO-PAUSE. At the end of each phase, we collected arterial blood gases, respiratory mechanics and basic hemodynamics. Total PEEP (i.e., PEEPtot=PEEPext + autoPEEP) and Pplat were assessed with 5-second end-expiratory, and 2-second end-inspiratory occlusions, respectively. Driving airway pressure (ΔP) was computed as Pplat - PEEPtot, normalized elastance (ERS-n) as driving pressure (ΔP)/VtPBW and inspiratory airway resistance (Raw) as (Peak pressure [Ppeak] - Pplat) / V ̇.
We hypothesized that ventilation efficiency would be better during VentPAUSE, and wanted to evaluate whether this strategy would have allowed to reduce VE while keeping the same CO2 obtained without EIP. Accordingly, and assuming a constant CO2 production, we calculated the predicted VE during VentPAUSE to maintain the same CO2 measured during VentNO-PAUSE with the formula :
Predicted VE_( (Vent_PAUSE))=█(〖PaCO_(2 )〗_((Vent_PAUSE ) ) )/〖PaCO_2〗_((Vent_(NO-PAUSE) ) ) × VE used during the study phases.
This allowed to calculate to what extent it would have been possible to reduce VE (VEpred) and RR (RRpred) using the experimental strategy. We additionally calculated the predicted prolongation of expiration using the new RRpred as: TE-pred = (60/RRpred) - TI.
We calculated the ventilatory ratio as an indice reflecting physiological dead-space ventilation (VD/VT).
- Being tested
- END INSPIRATORY PAUSE DURING CONTROLLED VENTILATION, NO PAUSE VENTILATION
- Keywords
- mechanical ventilation, COPD, End-inspiratory pause, AutoPEEP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Positive-Pressure Respiration, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
END INSPIRATORY PAUSE DURING CONTROLLED VENTILATIONOther
PATIENTS WILL BE VENTILATED WITH END-INSPIRATORY PAUSE AND HIGH INSPIRATORY FLOW DURING CONTROLED VENTILATION
NO PAUSE VENTILATIONOther
PATIENTS WILL BE VENTILATED IN VOLUME CONTROLLED VENTILATION WITHOUT END-INSPIRATORY PAUSE
| Study group | Role | What they receive |
|---|---|---|
| NO PAUSE ventilation | Active comparator | Patients will be ventilated in volume-controlled mode with square-flow waveform, without end-inspiratory pause, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%. Receives: Other: NO PAUSE VENTILATION |
| PAUSE ventilation | Experimental | Patients will be ventilated in volume-controlled mode with square-flow waveform, where total Ti will be the same that during NO PAUSE ventilation, but inspiratory flow will be increased and a part of the total inspiratory time will be replaced by end-inspiratory pause of 0.3-0.5 s. All the remaining parameters will be equal to the NO PAUSE ventilation phase. Tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%. Receives: Other: END INSPIRATORY PAUSE DURING CONTROLLED VENTILATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pressure of carbon dioxide
Arterial pressure of carbon dioxide
Measured: 30 minutes
arterial pH
arterial pH
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanatorio Anchorena San Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Accoce, Sanatorio Anchorena San Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207967
- Sponsor's protocol ID
- 10/2024
- Acronym
- PYE
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential data
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-Inspiratory Pause Enhances Ventilation Efficiency Without Affecting autoPEEP in COPD Patients During Controlled Ventilation
- ClinicalTrials.gov ID
- NCT07207967
- Acronym / sponsor ID
- PYE / 10/2024
- Keywords
- mechanical ventilation, COPD, End-inspiratory pause, AutoPEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sanatorio Anchorena San MartinUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Oct 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.
In patients with airflow obstruction receiving mechanical ventilation, an important objective is to reduce lung hyperinflation often using controlled hypoventilation. At the same time, maintaining acceptable gas exchange is challenging, as major reductions in minute ventilation (VE) raises carbon dioxide (CO2) and causes respiratory acidosis, which may lead to adverse physiological consequences.
Relatively prolonged end-inspiratory pause (EIP) has been shown to optimize CO2 clearance in hypoxemic mechanically ventilated patients. Previous data suggests that, at equivalent total inspiratory-time (TI), shorter insufflations followed by EIP can enhance CO2 elimination in acute lung injury. Adding EIP is classically discouraged in chronic obstructive pulmonary disease (COPD) because - at constant respiratory rate (RR) - prolonging inspiration reduces expiratory time (TE), and can worsen hyperinflation and impair hemodynamics.
In this study, we assessed whether a breathing pattern characterized by high inspiratory flow (V ̇) plus EIP could reduce PaCO2 without inducing hyperinflation, compared with same inspiration-to-expiration time (I:E) and a ventilation pattern without EIP in patients with COPD undergoing controlled hypoventilation.
Methods We performed a prospective, single-center, cross-over, randomized trial (ethical approval #10/2024) including deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort. Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria. Patient's next of kin signed the informed consent.
At inclusion, we collected demographic characteristics and baseline respiratory variables. A CT-emphysema score, using computed tomographies obtained within 24 hs of intubation for clinical reasons, was calculated (A.R, a pulmonologist specialized in medical imaging). Each lung was divided into 3 regions (superior, medium and inferior) based on anatomical references and were graded as no emphysema (score 0), emphysema ≤25% (score 1), ≤50% (score 2), ≤75% (score 3) and >75% (score 4). Scores of the six regions were summed to obtain the total score, giving a minimum 0 and a maximum of 24 points. Total scores ≥ 2 are indicative of emphysema.
Patients were ventilated in volume-controlled mode with square-flow waveform, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) was set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%.
Two ventilation strategies, each one applied for 30 minutes, were randomly evaluated: a) ventilation without EIP, using initial ventilator settings (VentNO-PAUSE); b) ventilation with EIP (VentPAUSE), in which V ̇ was increased and 40-50% of the total inspiratory time (TI) was replaced by EIP; the remaining setting were equal to VentNO-PAUSE. At the end of each phase, we collected arterial blood gases, respiratory mechanics and basic hemodynamics. Total PEEP (i.e., PEEPtot=PEEPext + autoPEEP) and Pplat were assessed with 5-second end-expiratory, and 2-second end-inspiratory occlusions, respectively. Driving airway pressure (ΔP) was computed as Pplat - PEEPtot, normalized elastance (ERS-n) as driving pressure (ΔP)/VtPBW and inspiratory airway resistance (Raw) as (Peak pressure [Ppeak] - Pplat) / V ̇.
We hypothesized that ventilation efficiency would be better during VentPAUSE, and wanted to evaluate whether this strategy would have allowed to reduce VE while keeping the same CO2 obtained without EIP. Accordingly, and assuming a constant CO2 production, we calculated the predicted VE during VentPAUSE to maintain the same CO2 measured during VentNO-PAUSE with the formula :
Predicted VE_( (Vent_PAUSE))=█(〖PaCO_(2 )〗_((Vent_PAUSE ) ) )/〖PaCO_2〗_((Vent_(NO-PAUSE) ) ) × VE used during the study phases.
This allowed to calculate to what extent it would have been possible to reduce VE (VEpred) and RR (RRpred) using the experimental strategy. We additionally calculated the predicted prolongation of expiration using the new RRpred as: TE-pred = (60/RRpred) - TI.
We calculated the ventilatory ratio as an indice reflecting physiological dead-space ventilation (VD/VT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO PAUSE ventilation | Active comparator | Other: NO PAUSE VENTILATIONPatients will be ventilated in volume-controlled mode with square-flow waveform, without end-inspiratory pause, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%. |
| PAUSE ventilation | Experimental | Other: END INSPIRATORY PAUSE DURING CONTROLLED VENTILATIONPatients will be ventilated in volume-controlled mode with square-flow waveform, where total Ti will be the same that during NO PAUSE ventilation, but inspiratory flow will be increased and a part of the total inspiratory time will be replaced by end-inspiratory pause of 0.3-0.5 s. All the remaining parameters will be equal to the NO PAUSE ventilation phase. Tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) will be set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort
- sign the informed consent
Key exclusion criteria (1 listed)
- Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria.
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 |
|---|---|---|
| END INSPIRATORY PAUSE DURING CONTROLLED VENTILATIONPATIENTS WILL BE VENTILATED WITH END-INSPIRATORY PAUSE AND HIGH INSPIRATORY FLOW DURING CONTROLED VENTILATION | Other | PAUSE ventilation |
| NO PAUSE VENTILATIONPATIENTS WILL BE VENTILATED IN VOLUME CONTROLLED VENTILATION WITHOUT END-INSPIRATORY PAUSE | Other | NO PAUSE ventilation |
Primary outcome
Arterial pressure of carbon dioxide
Time frame: 30 minutes
Arterial pressure of carbon dioxide
arterial pH
Time frame: 30 minutes
arterial pH
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 16 Apr 2026.
- Individual participant dataSharing planned: No. confidential 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NO PAUSE VENTILATION in people with COPD (Chronic Obstructive Pulmonary Disease), run by Sanatorio Anchorena San Martin at 1 site in Argentina.
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 2 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 16 Apr 2026. 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 Argentina. 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?
Arterial pressure of carbon dioxide (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.