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Obstructive Airway DiseasesNCT07611409

Physiological Effects of External PEEP in Controlled Mechanical Ventiated Patients With autoPEEP

A study testing PEEP titration in people with Obstructive Airway Diseases, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This experimental physiologic study is conducted to determine the effect of different mechanical ventilation settings (in terms of positive end-expiratory pressure) on patients receiving mechanical ventilation with expiratory flow obstruction and autoPEEP. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Airway Diseases
What is being tested?
PEEP titration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteArgentina
Study dates
10 Sep 2025to 10 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 > 17 years. Invasive mechanical ventilation (endotracheal tube or tracheostomy) in controlled mode, with SpO2 > 90%, for more than 12 hours.
  • No contraindications for abdominal compression. AutoPEEP greater than 3 cmH2O measured during mechanical ventilation with full support and ZEEP.
  • Full mechanical respiratory support, with no respiratory muscle activity (inspiratory or expiratory).
  • -

Who cannot join

  • Cardiovascular instability: Hypotension (MAP < 60 mmHg), hypertension (SBP > 180 mmHg), heart rate < 40 bpm or > 150 bpm.
  • Refusal to participate in the study by a family member (without signed informed consent).
  • Evidence of air leak: Pneumothorax, subcutaneous emphysema, pneumomediastinum. Intracranial hypertension (ICP > 20 mmHg). Pregnant patient. Body Mass Index greater than 40 kg/m².

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Santojanni

    Buenos Aires

Other trials in Argentina

About this study

Official title: Effects of External PEEP in Controlled Mechanical Ventiated Patients With autoPEEP. A Physiological Study

This experimental physiologic study is conducted to determine the effect of different mechanical ventilation settings (in terms of positive end-expiratory pressure) on patients receiving mechanical ventilation with expiratory flow obstruction and autoPEEP. The main question it aims to answer In patients with autoPEEP, what is the effect of applying external PEEP on gas exchange and the lung emptying pattern in patients with total ventilatory support? Participants must comply:

  • Age > 17 years.
  • Invasive mechanical ventilation (endotracheal tube or tracheostomy) in controlled mode, with SpO2 > 90%, for more than 12 hours.
  • No contraindications for abdominal compression.
  • Presence of autoPEEP greater than 3 cmH2O measured in mechanical ventilation with total support and ZEEP.
  • Total mechanical respiratory support, without respiratory muscle activity (inspiratory or expiratory).
Read the detailed description

The study includes patients with controlled mechanical ventilation and autoPEEP. By programming different levels of external PEEP, its effect on respiratory mechanics, gas exchange, and pulmonary emptying constants will be determined. Once included in the study, participants remain on the established mechanical ventilation schedule.Subsequently, they will remain for 5 minutes at each programmed PEEP level, during which the variables under study will be recorded. They will remain at 3 PEEP levels for 15 minutes before taking arterial blood gas samples. The variables under study will be recorded and stored in a respiratory monitor and an electrical impedance tomograph, and subsequently analyzed offline.

Being tested
PEEP titration
Keywords
External PEEP, intrinsic PEEP, controlled mechanical ventilation
Medical subject headings
Positive-Pressure Respiration, Intrinsic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP titrationOther

    External PEEP will be increased by 3 cmH₂O, from 0 to 15 cmH₂O.

Study groups in NCT07611409
Study groupRoleWhat they receive
PEEP titrationExperimentalNot described
Receives: Other: PEEP titration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the expiratory time constant as a function of external PEEP.

    Methodology: the expiratory pattern is defined through the expiratory time constant at different PEEP levels relative to the reference (ZEEP).

    Measured: 1 hour

Secondary outcomes (1)

  1. To evaluate thel effect of external PEEP in gas exchange respect to reference (ZEEP)

    Gas exchange: Methodology: Arterial blood gas samples (PaO2 and PaCO2 in mmHg) are taken after a 15-minute stability period at three time points: without external PEEP (reference), and 3 cmH2O below and 3 cmH2O above final PEEP.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start10 Sep 2025
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion10 Apr 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07611409
Sponsor's protocol ID
Hospitalsantojanni.2
Status last verified
May 2026
First submitted
25 Jan 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lourens MS, van den Berg B, Aerts JG, Verbraak AF, Hoogsteden HC, Bogaard JM. Expiratory time constants in mechanically ventilated patients with and without COPD. Intensive Care Med. 2000 Nov;26(11):1612-8. doi: 10.1007/s001340000632.

    PubMed 11193266

  • Roesthuis LH, van der Hoeven JG, Guerin C, Doorduin J, Heunks LMA. Three bedside techniques to quantify dynamic pulmonary hyperinflation in mechanically ventilated patients with chronic obstructive pulmonary disease. Ann Intensive Care. 2021 Dec 4;11(1):167. doi: 10.1186/s13613-021-00948-9.

    PubMed 34862945

  • Lemyze M, Favory R, Alves I, Perez T, Mathieu D. Manual compression of the abdomen to assess expiratory flow limitation during mechanical ventilation. J Crit Care. 2012 Feb;27(1):37-44. doi: 10.1016/j.jcrc.2011.05.011. Epub 2011 Jul 27.

    PubMed 21798707

  • Pepe PE, Marini JJ. Occult positive end-expiratory pressure in mechanically ventilated patients with airflow obstruction: the auto-PEEP effect. Am Rev Respir Dis. 1982 Jul;126(1):166-70. doi: 10.1164/arrd.1982.126.1.166.

    PubMed 7046541

  • Dawson SV, Elliott EA. Wave-speed limitation on expiratory flow-a unifying concept. J Appl Physiol Respir Environ Exerc Physiol. 1977 Sep;43(3):498-515. doi: 10.1152/jappl.1977.43.3.498.

    PubMed 914721

  • Valta P, Corbeil C, Lavoie A, Campodonico R, Koulouris N, Chasse M, Braidy J, Milic-Emili J. Detection of expiratory flow limitation during mechanical ventilation. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1311-7. doi: 10.1164/ajrccm.150.5.7952558.

    PubMed 7952558

  • HYATT RE. The interrelationships of pressure, flow, and volume during various respiratory maneuvers in normal and emphysematous subjects. Am Rev Respir Dis. 1961 May;83:676-83. doi: 10.1164/arrd.1961.83.5.676. No abstract available.

    PubMed 13717137

  • Kimball WR, Leith DE, Robins AG. Dynamic hyperinflation and ventilator dependence in chronic obstructive pulmonary disease. Am Rev Respir Dis. 1982 Dec;126(6):991-5. doi: 10.1164/arrd.1982.126.6.991.

    PubMed 6960747

  • Jonson B, Nordstrom L, Olsson SG, Akerback D. Monitoring of ventilation and lung mechanics during automatic ventilation. A new device. Bull Physiopathol Respir (Nancy). 1975 Sep-Oct;11(5):729-43.

    PubMed 1218293

  • Bergman NA. Intrapulmonary gas trapping during mechanical ventilation at rapid frequencies. Anesthesiology. 1972 Dec;37(6):626-33. doi: 10.1097/00000542-197212000-00011. No abstract available.

    PubMed 4652779

Questions about this trial

What is this clinical trial studying?

A study testing PEEP titration in people with Obstructive Airway Diseases, run by Hospital Donación Francisco Santojanni 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 May 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?

This study is still under way. Results are not available in the source record yet.

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 evaluate the expiratory time constant as a function of external PEEP. (time frame: 1 hour). 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 NCT07611409, 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 28 May 2026.

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