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The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation

The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03511651
Enrollment
30
Registered
2018-04-30
Start date
2020-08-01
Completion date
2021-03-31
Last updated
2020-05-29

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

Conditions

Acute Respiratory Distress Syndrome, Functional Residual Capacity, Mechanical Ventilation

Brief summary

Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the optimal PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at different PEEP levels remains unknown.

Detailed description

Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the optimal PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Passive spirometry has long been used to measure the lung recruitment volume (VREC). A prolonged expiration to zero end-expiratory pressure (ZEEP) or airway release maneuver is required and PEEP induced lung volume change above functional residual capacity (FRC) is measured. This technique assumes that FRC does not change at different PEEP levels. This assumption that PEEP has no effect on FRC can date back to the study of Valta et al in the early 1990s. Using respiratory inductive plethysmography (RIP), they found that in ALI/ARDS patients, after expiring from different PEEP levels to ZEEP, the plethysmography signal returned to the same baseline value. They concluded that FRC does not change with PEEP, and that changes of EELV are attributable only to change in ∆EELV. Ranieri et al arrived at similar conclusions by measuring differences in lung volumes at different PEEP levels using standardized pressure-volume (P-V) curves derived from the ventilator circuit monitors. However, Patroniti et al found an elevation of FRC as increasing of PEEP in patients with ARDS. In this study, FRC was measured with the helium dilution technique, and concluded that neglecting this effect resulted in marked underestimation of VREC. Whether the FRC changes at different PEEP levels remains controversial. The aim of the study is to assess the effect of PEEP on FRC during mechanical ventilation.

Interventions

PROCEDUREPEEP

Two PEEP levels will be used during mechanical ventilation.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

include: 1. Diagnosed with ARDS according to the Berlin Definition; 2. Age 18-80 years; 3. Ventilated with volume-controlled ventilation using constant flow; 4. Deep sedation (RASS -4 to -5) and absence of spontaneous breathing (i.e., no triggering during tidal breaths and no inspiratory effort during a 5-second end-expiratory hold).

Exclusion criteria

include: 1. Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; 2. Chest wall and/or abdominal injuries; 3. Evidence suggesting reduced chest wall compliance, such as existing large pleural effusion, thoracic trauma and intra-abdominal hypertension (i.e., intra-abdominal pressure \> 20 mmHg). 4. Presence of pacemaker, defibrillator, and implantable pumps).

Design outcomes

Primary

MeasureTime frameDescription
The change of FRC1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2OEELV measurement by ICU ventilator; PEEP Volume measured through airway release. FRC will be calculated as EELV minus PEEP volume. Correlation between EELV, PEEP volume, FRC at two different PEEP levels are tested by linear regression analysis.

Secondary

MeasureTime frameDescription
The change of regional EELV1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2ORegional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O
The change of homogeneity of distribution of tidal volume1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2OEIT is used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.
The change of PaO2/FiO2 Ratio1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2OObtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator
The change of regional FRC1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2ORegional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O
The change of blood pressure1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2OThe change of blood pressure will be measured
The change of driving Pressure1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2OThe change of driving pressure will be measured.

Countries

China

Contacts

Primary ContactJian-Xin Zhou, MD
zhoujx.cn@icloud.com8610 67096579

Outcome results

None listed

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