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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03511651
• Other study ID #: KY2018-004-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: May 2020
• Source: Capital Medical University
• Contact: Jian-Xin Zhou, MD
• Phone: 8610 67096579
• Email: zhoujx.cn[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Functional Residual Capacity
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• PEEP
Two PEEP levels will be used during mechanical ventilation.

Locations

Country	Name	City	State
China	Jian-Xin Zhou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of FRC	EELV 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.	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of PaO2/FiO2 Ratio	Obtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of regional EELV	Regional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of homogeneity of distribution of tidal volume	EIT 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.	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of driving Pressure	The change of driving pressure will be measured.	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of regional FRC	Regional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary	The change of blood pressure	The change of blood pressure will be measured	1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O