- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611409
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
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Buenos Aires, Argentina
- Hospital Santojanni
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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).
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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
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
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External PEEP will be increased by 3 cmH₂O, from 0 to 15 cmH₂O.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To evaluate the expiratory time constant as a function of external PEEP.
Time Frame: 1 hour
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Methodology: the expiratory pattern is defined through the expiratory time constant at different PEEP levels relative to the reference (ZEEP).
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1 hour
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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.
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1 hour
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hospitalsantojanni.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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