Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)

NCT00400881 | Completed Results

• 1 other identifier: E06040
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; weaning; respiratory failure; spontaneous breathing trial

Outcome Measures

Primary Outcomes (1)

• Duration of Weaning Time

  Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.

  days

Secondary Outcomes (1)

• Duration of Mechanical Ventilation

  days

Study Arms (2)

Continuous PAP (CPAP)

NO INTERVENTION

CPAP (continuous positive airway pressure). 5 cm H2O.

Automatic tube compensation (ATC)

EXPERIMENTAL

ATC is a new mode of ventilation being compared with traditional one (CPAP). ATC is a mode of ventilation of the same device (mechanical ventilator), not a new device. The pressure in this modes varies according the mechanical parameters of the respiratory system that are automatically calculated by this mode. This is the intervention arm.

Other: automatic tube compensation

Interventions

automatic tube compensation OTHER

new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.

Automatic tube compensation (ATC)

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 of age or older
• on mechanical ventilation at Thomason Hospital Intensive Care Unit for more than 24 hours
• about to undergo SBT by the current institutional protocol for weaning assessment ordered by their treating physician
• availability of informed consent from patient or next of kin

You may not qualify if:

• patients for whom a decision has been made not to reinstitute ventilatory assistance under any circumstance
• pregnancy
• patients not considered for discontinuation of mechanical ventilation on the day of SBT

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

University Medical Center Hospital

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

General ICU population. Two subjects in each group were randomized and data collected but were not included in analysis per protocol due to needing re-intubation for upper airway obstruction.

Results Point of Contact

• Title: Juan Figueroa-Casas
• Organization: Texas Tech University

juan.figueroa@ttuhsc.edu

915 5456626

Study Officials

• Juan B Figueroa-Casas, MD

  Assistant Professor, Texas Tech University HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 9, 2017
• Results First Posted: May 17, 2012

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)