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The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony

Primary Purpose

Critical Illness

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Higher PEEP setting

Lower PEEP setting

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring patient ventilator asynchrony, positive end expiratory pressure

Eligibility Criteria

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

Inclusion Criteria:

Patients ≧ 18 years old
Patients with moderate to severe ARDS under mechanical ventilation＊＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)

Exclusion Criteria:

Lack of informed consent
Continuous neuromuscular blockade at enrollment
DNR (do-not-resuscitate)
Moribund patient not expected to survive 24 hours
Massive hemoptysis
Increased intracranial pressure (> 18 mmHg)
Existence or high risk of pneumothorax
Known pregnancy
Actual body weight exceeding 1 kg/cm
Patient judged to be inappropriate for the trial by intensivist

Sites / Locations

Osaka University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

A group from higher PEEP to lower PEEP

A group from lower PEEP to higher PEEP

Arm Description

Patient allocated for this arm are received from higher to lower PEEP setting.

Patient allocated for this arm are received from lower to higher PEEP setting.

Outcomes

Primary Outcome Measures

Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.

Secondary Outcome Measures

Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.

The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP

Minute volume at higher and lower PEEP

The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.

Full Information

NCT ID

NCT04951960

First Posted

November 1, 2020

Last Updated

July 11, 2021

Sponsor

Osaka University

1. Study Identification

Unique Protocol Identification Number

NCT04951960

Brief Title

The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony

Official Title

The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony in Patients With Acute Respiratory Distress Syndrome: a Cross-Over Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

March 31, 2022 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Osaka University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.

Detailed Description

The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

patient ventilator asynchrony, positive end expiratory pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Participants, their legal representatives, and outcomes assessor are blinded.

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A group from higher PEEP to lower PEEP

Arm Type

Other

Arm Description

Patient allocated for this arm are received from higher to lower PEEP setting.

Arm Title

A group from lower PEEP to higher PEEP

Arm Type

Other

Arm Description

Patient allocated for this arm are received from lower to higher PEEP setting.

Intervention Type

Other

Intervention Name(s)

Higher PEEP setting

Intervention Description

PEEP levels are determined according to the higher PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.

Intervention Type

Other

Intervention Name(s)

Lower PEEP setting

Intervention Description

PEEP levels are determined according to the lower PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.

Primary Outcome Measure Information:

Title

Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.

Time Frame