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NCT Number: NCT07611409

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obstructive Airway Diseases Positive-Pressure Respiration, Intrinsic Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Santojanni

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEEP titration

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Donación Francisco Santojanni

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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