NCT02376647

Brief Summary

This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without acute respiratory distress syndrome (ARDS).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 13, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
7 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

February 13, 2015

Last Update Submit

September 21, 2022

Conditions

Mechanical VentilationAcute Respiratory Distress Syndrome

Keywords

PatientsARDS diagnosis

Outcome Measures

Primary Outcomes (1)

  • Mean driving pressure between Day 1 and Day 3

    From Day 1 to Day 3 after randomization

Secondary Outcomes (17)

  • Rate of investigators adering to study procedures

    Days 1 to 7

  • Rate of driving pressure equal or lower than 13 cmH2O

    Days 1 to 3 after randomization

  • Mean of positive end expiratory pressure (PEEP) from day 1 to 7

    Days 1 to 7

  • Mean tidal volume from day 1 to 7

    Days 1 to 7

  • Mean static compliance of the respiratory system from day 1 to 7

    Days 1 to 7

  • +12 more secondary outcomes

Study Arms (2)

Driving pressure limited ventilation

EXPERIMENTAL

Driving pressure limited ventilation (≤13cmH2O)

Other: Driving pressure limited ventilation

Conventional ventilation

ACTIVE COMPARATOR

Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O)

Other: Conventional ventilation

Interventions

Driving pressure limited ventilationOTHER

Investigators will use volume controlled (or pressure support ventilation) and adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). Investigators will not limit plateau pressure in this arm. Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment.

Driving pressure limited ventilation
Conventional ventilationOTHER

Investigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute).

Conventional ventilation

Eligibility Criteria

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

You may qualify if:

  • Patients on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.

You may not qualify if:

  • Less than 18 years old
  • Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (\<7 days) acute coronary syndrome.
  • Patients in which a high probability of death within 24 hours is anticipated.
  • Patients under exclusive palliative care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Biasi Cavalcanti

São Paulo, São Paulo, 04005000, Brazil

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Alexandre B Cavalcanti, MD, PhD

    Hospital do Coração(Heart Hospital)

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

February 13, 2015

First Posted

March 3, 2015

Study Start

March 1, 2022

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

BR(1)