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

Primary Purpose

Mechanical Ventilation, Acute Respiratory Distress Syndrome, Functional Residual Capacity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEEP
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Jian-Xin Zhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

FRC at clinical PEEP level

FRC at clinical PEEP + 5cmH2O

Arm Description

Measuring FRC at clinical PEEP level

Increasing PEEP to clinical PEEP + 5cmH2O

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The change of PaO2/FiO2 Ratio
Obtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator
The change of regional EELV
Regional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O
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.
The change of driving Pressure
The change of driving pressure will be measured.
The change of regional FRC
Regional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O
The change of blood pressure
The change of blood pressure will be measured

Full Information

First Posted
April 8, 2018
Last Updated
May 28, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03511651
Brief Title
The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation
Official Title
The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Acute Respiratory Distress Syndrome, Functional Residual Capacity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FRC at clinical PEEP level
Arm Type
Other
Arm Description
Measuring FRC at clinical PEEP level
Arm Title
FRC at clinical PEEP + 5cmH2O
Arm Type
Experimental
Arm Description
Increasing PEEP to clinical PEEP + 5cmH2O
Intervention Type
Procedure
Intervention Name(s)
PEEP
Intervention Description
Two PEEP levels will be used during mechanical ventilation.
Primary Outcome Measure Information:
Title
The change of FRC
Description
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.
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary Outcome Measure Information:
Title
The change of PaO2/FiO2 Ratio
Description
Obtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Title
The change of regional EELV
Description
Regional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Title
The change of homogeneity of distribution of tidal volume
Description
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.
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Title
The change of driving Pressure
Description
The change of driving pressure will be measured.
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Title
The change of regional FRC
Description
Regional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Title
The change of blood pressure
Description
The change of blood pressure will be measured
Time Frame
1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria include: Diagnosed with ARDS according to the Berlin Definition; Age 18-80 years; Ventilated with volume-controlled ventilation using constant flow; 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: Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; Chest wall and/or abdominal injuries; 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). Presence of pacemaker, defibrillator, and implantable pumps).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Xin Zhou, MD
Phone
8610 67096579
Email
zhoujx.cn@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Xin Zhou, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jian-Xin Zhou
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Xin Zhou, MD
Phone
8610 67096579
Email
zhoujx.cn@icloud.com

12. IPD Sharing Statement

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

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