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

May 20, 2026 updated by: Marco Guillermo Bezzi, Hospital Donación Francisco Santojanni

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).

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Hospital Santojanni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

-

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEP titration
External PEEP will be increased by 3 cmH₂O, from 0 to 15 cmH₂O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the expiratory time constant as a function of external PEEP.
Time Frame: 1 hour
Methodology: the expiratory pattern is defined through the expiratory time constant at different PEEP levels relative to the reference (ZEEP).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate thel effect of external PEEP in gas exchange respect to reference (ZEEP)
Time Frame: 1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

April 10, 2027

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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