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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07611409
Enrollment
20
Registered
2026-05-28
Start date
2025-09-10
Completion date
2027-04-10
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Airway Diseases

Keywords

External PEEP, intrinsic PEEP, controlled mechanical ventilation

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).

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.

Interventions

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

Sponsors

Hospital Donación Francisco Santojanni
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the expiratory time constant as a function of external PEEP.1 hourMethodology: the expiratory pattern is defined through the expiratory time constant at different PEEP levels relative to the reference (ZEEP).

Secondary

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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026