NCT01472302

Brief Summary

Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2012

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

November 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

November 11, 2011

Last Update Submit

March 5, 2014

Conditions

Respiratory FailureAll Intubated Patients

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation

    1 year

Study Arms (2)

ASV

EXPERIMENTAL

Adaptive Support Ventilation

Device: Adaptive Support Ventilation

PCV

ACTIVE COMPARATOR

Pressure Controlled Ventilation

Device: Pressure Controlled Ventilation

Interventions

Adaptive Support VentilationDEVICE

Ventilation protocol according to the patients ideal body weight

ASV
Pressure Controlled VentilationDEVICE

Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU

PCV

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubated and mechanically ventilated ICU patients for more than 24 hours

You may not qualify if:

  • Patient with a tracheostomy
  • Patients under home mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit

Izmir, Yenisehir, 35550, Turkey (Türkiye)

Location

Related Publications (1)

  • Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.

    PMID: 25742308DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Cenk Kirakli, MD

    Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Director of ICU

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 16, 2011

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

TU(1)