Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

Acute Respiratory Failure Clinical Trial

Official title:

Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632320
• Other study ID #: VGHIRB No.:93-09-02A
• Secondary ID: Grant 94CM-TMU-1
• Status: Completed
• Phase: N/A
• First received: March 2, 2008
• Last updated: March 7, 2008
• Start date: October 2004
• Est. completion date: August 2005

Study information

• Verified date: March 2008
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.

Description:

98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• intubated medical patients with mechanically ventilated more than 48 hours

• clinically ready for weaning

• Glasgow coma scales were at least 8

• their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable

Exclusion Criteria:

• having ongoing lung or neuromuscular disease and signs of increased intracranial pressure

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
Taiwan	Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies.		Before the patient processing weaning trials	No
Secondary	Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions.		Before the patient processing weaning trials	No