NCT00910286

Brief Summary

Objective: To compare termination criteria (TC) of pressure support ventilation (PSV). Design: Randomized cross-over clinical trial. Setting: Intensive Care Units. Patients: Sixteen patients on PSV with ability to answer a visual analog scale (VAS). Protocol and Measurements: Each patient was ventilated with two different TC ventilators, fixed and automatic, with measurements of ventilatory mechanic variables, breathing comfort and asynchrony patterns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

3 years

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Keywords

Pressure support ventilationcycling off criteriaexpiratory triggerpatient-ventilator interactionpatient comfort

Outcome Measures

Primary Outcomes (1)

  • comfort

    30 minutes

Study Arms (1)

VENTILATOR WEANING

OTHER

Two ventilators with different flow termination criteria (TC) were compared: Servo 300 (Siemens-Elema, Sweden) with fixed TC (5% of peak inspiratory flow) and Newport E500 (Newport Medical Instruments, CA) with automatic TC (varies between 5% to 55%). Each patient remained three hours in the protocol, one hour in each ventilator, after been randomized to one of two sequences of 3 steps: Fixed 5% / Automatic / Fixed 5% or Automatic / Fixed 5% / Automatic . The PS, the positive end expiratory pressure (PEEP), the inspiratory oxygen fraction (FiO2) and the pressure trigger sensitivity levels were unchanged during the protocol.

Other: Pulmonary Ventilator

Interventions

The aim of the present study was to compare two different cycling off modes in PSV, a fixed and other automatic, about ventilatory mechanic variables, breathing comfort and patient-ventilator asynchrony patterns

Also known as: pressure support
VENTILATOR WEANING

Eligibility Criteria

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

You may qualify if:

  • Patients under PSV for more than 24 hours,
  • Age \> 18 years
  • Ability to answer to a symptom visual analog scale (VAS)

You may not qualify if:

  • Hemodynamic instability (use of vasoactive drugs like dopamine, dobutamine or norepinephrine)
  • Bronchopleural fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 91900580, Brazil

Location

Related Publications (2)

  • Du HL, Yamada Y. Expiratory asynchrony. Respir Care Clin N Am. 2005 Jun;11(2):265-80. doi: 10.1016/j.rcc.2005.02.001.

    PMID: 15936693BACKGROUND
  • Hoff FC, Tucci MR, Amato MB, Santos LJ, Victorino JA. Cycling-off modes during pressure support ventilation: effects on breathing pattern, patient effort, and comfort. J Crit Care. 2014 Jun;29(3):380-5. doi: 10.1016/j.jcrc.2014.01.015. Epub 2014 Jan 29.

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • josue a victorino, phd

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

December 1, 2004

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations