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

Not Applicable

• Conditions: Critical Illness
• Interventions: Other: Higher PEEP setting; Other: Lower PEEP setting

• Registration Number: NCT04951960
• Lead Sponsor: Osaka University

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients ≧ 18 years old
2. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A group from higher PEEP to lower PEEP	Lower PEEP setting	Patient allocated for this arm are received from higher to lower PEEP setting.
A group from lower PEEP to higher PEEP	Higher PEEP setting	Patient allocated for this arm are received from lower to higher PEEP setting.
A group from lower PEEP to higher PEEP	Lower PEEP setting	Patient allocated for this arm are received from lower to higher PEEP setting.
A group from higher PEEP to lower PEEP	Higher PEEP setting	Patient allocated for this arm are received from higher to lower PEEP setting.

Primary Outcome Measures

Name	Time	Method
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.	Through study completion (up to 24 hours)

Secondary Outcome Measures

Name	Time	Method
Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.	Through study completion (up to 24 hours)
Minute volume at higher and lower PEEP	Through study completion (up to 24 hours)
The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.	Through study completion (up to 24 hours)
The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP	Through study completion (up to 24 hours)

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan