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

NCT03511651 | Unknown DMC

• 1 other identifier: KY2018-004-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Acute Respiratory Distress Syndrome; Functional Residual Capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The change of PaO2/FiO2 Ratio

  1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

• The change of regional EELV

  1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

• The change of homogeneity of distribution of tidal volume

  1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

• The change of driving Pressure

  1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

• The change of regional FRC

  1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

Study Arms (2)

FRC at clinical PEEP level

OTHER

Measuring FRC at clinical PEEP level

Procedure: PEEP

FRC at clinical PEEP + 5cmH2O

EXPERIMENTAL

Increasing PEEP to clinical PEEP + 5cmH2O

Procedure: PEEP

Interventions

PEEP PROCEDURE

Two PEEP levels will be used during mechanical ventilation.

FRC at clinical PEEP + 5cmH2O; FRC at clinical PEEP level

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jian-Xin Zhou, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 67096579; zhoujx.cn@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 30, 2018
• Study Start: August 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

CN (1)