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Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation

Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04141293
Enrollment
0
Registered
2019-10-28
Start date
2017-08-01
Completion date
2021-11-01
Last updated
2024-02-20

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

Conditions

ARDS, Human

Brief summary

According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver. Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations. The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.

Interventions

Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.

Sponsors

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

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

Inclusion criteria

* orotracheal intubation * pressure supported ventilation * moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O

Exclusion criteria

* age \< 18 years * pregnancy * previous pulmonary resection, pulmonectomy * clinically verified, end-stage COPD * severe hemodynamic instability (i.e. refractory shock to vasopressors) * severe emphysema and/or spontaneous pneumothorax in past medical history * contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)

Design outcomes

Primary

MeasureTime frameDescription
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitmentApproximately 35 minutesChanges in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations

Secondary

MeasureTime frameDescription
Changes in pulmonary air contentApproximately 30 miniutesChanges in pulmonary atelectasis will be assessed by electrical impedance tomography (EIT) - mean impedance variation in % and will be compared with arterial oxygen content.
Changes in arterial oxygen contentApproximately 5 minutesPre- and post-recruitment arterial oxygenation (PaO2 mmHg) will be measured by blood gas machine and will be compared to EIT measurements.
Changes in hemodynamic parameters (SV)35 minutesChanges in stroke volume (ml)
Changes in left and right ventricular volume (systolic ventricular interdependence)Approximately 3 minutesLeft ventricular end-systolic eccentricity index will be assessed by transthoracal echocardiogarphy and will be compared with transpulmonary pressure alterations.
Changes in hemodynamic parameters (HR)35 minutesChanges in heart rate (1/min)
Changes in hemodynamic parameters (CI)35 minutesChanges in cardiac index (l/min/2m)
Changes in hemodynamic parameters (MAP)35 minutesChanges in mean arterial pressure (mmHg)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026