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

NCT04951960 | Unknown

• 1 other identifier: PEEPPVA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

patient ventilator asynchrony; positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

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

  Through study completion (up to 24 hours)

Secondary Outcomes (4)

• Asynchrony index of each types of patient ventilator asynchrony 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)

• 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)

Study Arms (2)

A group from higher PEEP to lower PEEP

OTHER

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

Other: Higher PEEP setting; Other: Lower PEEP setting

A group from lower PEEP to higher PEEP

OTHER

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

Other: Higher PEEP setting; Other: Lower PEEP setting

Interventions

Higher PEEP setting OTHER

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.

A group from higher PEEP to lower PEEP; A group from lower PEEP to higher PEEP

Lower PEEP setting OTHER

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.

A group from higher PEEP to lower PEEP; A group from lower PEEP to higher PEEP

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka University: lead

Study Sites (1)

Osaka University Hospital

Suita, Osaka, Japan

RECRUITING

MeSH Terms

Conditions

Critical Illness; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Takeshi Yoshida, M.D., Ph.D.

  Osaka University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takeshi Yoshida, M.D., Ph.D.

CONTACT

+81668795820; takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants, their legal representatives, and outcomes assessor are blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: July 7, 2021
• Study Start: November 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 15, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)