NCT07611409

Brief 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. 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Sep 2025Apr 2027

Study Start

First participant enrolled

September 10, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2027

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

January 25, 2026

Last Update Submit

May 20, 2026

Conditions

Obstructive Airway Diseases

Keywords

External PEEPintrinsic PEEPcontrolled mechanical ventilation

Outcome Measures

Primary Outcomes (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).

    1 hour

Secondary Outcomes (1)

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

    1 hour

Study Arms (1)

PEEP titration

EXPERIMENTAL
Other: PEEP titration

Interventions

PEEP titrationOTHER

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

PEEP titration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santojanni

Buenos Aires, Argentina

Location

Related Publications (10)

  • 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.

    PMID: 11193266BACKGROUND

  • 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.

    PMID: 34862945BACKGROUND

  • 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.

    PMID: 21798707BACKGROUND

  • 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.

    PMID: 7046541BACKGROUND

  • 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.

    PMID: 914721BACKGROUND

  • 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.

    PMID: 7952558BACKGROUND

  • 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.

    PMID: 13717137BACKGROUND

  • 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.

    PMID: 6960747BACKGROUND

  • 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.

    PMID: 1218293BACKGROUND

  • 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.

    PMID: 4652779BACKGROUND

MeSH Terms

Conditions

Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Licenciado Kinesiólogo Fisiatra. Clinical Professor. Respiratory Care Coordinator. Intansive Care Unit.

Study Record Dates

First Submitted

January 25, 2026

First Posted

May 28, 2026

Study Start

September 10, 2025

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

April 10, 2027

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)