NCT04241874

Brief Summary

Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

January 22, 2020

Last Update Submit

September 4, 2022

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Inspiratory effort

    The negative deflection in esophageal pressure during inspiration

    45 minutes

Secondary Outcomes (11)

  • Oxygenation

    45 minutes

  • Respiratory mechanics

    45 minutes

  • Lung mechanics

    45 minutes

  • Work of breathing

    45 minutes

  • Respiratory rate

    45 minutes

  • +6 more secondary outcomes

Study Arms (4)

Low PEEP and full inspiratory synchronization

EXPERIMENTAL

PEEP = 5 cmH2O + clinically selected pressure support (PSVclin)

Other: Mechanical Ventilation

High PEEP and full inspiratory synchronization

EXPERIMENTAL

PEEP = 15 cmH2O + clinically selected pressure support (PSVclin)

Other: Mechanical Ventilation

Low PEEP and inspiratory desynchronization

EXPERIMENTAL

PEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)

Other: Mechanical Ventilation

High PEEP and inspiratory desynchronization

EXPERIMENTAL

PEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)

Other: Mechanical Ventilation

Interventions

Mechanical VentilationOTHER

Respiratory support through mechanical ventilator

High PEEP and full inspiratory synchronizationHigh PEEP and inspiratory desynchronizationLow PEEP and full inspiratory synchronizationLow PEEP and inspiratory desynchronization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
  • (b) assisted ventilation, as prescribed by the attending physician
  • (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion

You may not qualify if:

  • Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Location

Related Publications (1)

  • Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.

    PMID: 38295949DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Giuseppe Bello, MD

    Fondazione Policlinico A. Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

  • Massimo Antonelli, MD

    Fondazione Policlinico A. Gemelli IRCCS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

May 1, 2021

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

IT(1)