Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation

Critical Care Clinical Trial

Official title:

Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation: a Randomized Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852891
• Other study ID #: 2004341 UFRGS
• Status: Completed
• Phase: N/A
• First received: February 26, 2009
• Last updated: February 26, 2009
• Start date: December 2005
• Est. completion date: August 2007

Study information

• Verified date: February 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

The objective of this study was to analyze changes in cardiac function using Doppler echocardiogram in critical patients during weaning from mechanical ventilation using two different weaning methods (pressure support and T-tube) and to compare a subgroup of patients: success vs. failure in weaning and patients with vs. without heart disease.

Description:

Weaning from mechanical ventilation (MV) involves physiological changes that can overload the cardiorespiratory system due to changes in the interaction between patient and ventilator.

This was a randomized crossover clinical trial that included patients in an intensive care unit (ICU) who had been on MV for more than 48 hours and who were considered ready for weaning. Cardiorespiratory variables, oxygenation, electrocardiogram (ECG) and Doppler echocardiogram findings were analyzed at baseline and after 30 minutes in each trial weaning method (PSV and T-tube). Comparisons were made between PSV and T-tube, weaning success and failure and patients with and without heart disease, using ANOVA and Student's t test. The level of significance was set at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients hemodynamically stable

• conscious (Glasgow scale = 13)

• with adequate gaseous exchange (O2 saturation = 95%, fraction of inspired oxygen (FiO2) = 40% and positive end-expiratory pressure (PEEP) = 5

• with no acidosis or alkalosis)

• normal electrolyte levels

• presence of respiratory drive

• informed consent was signed by the patients and/or family members

Exclusion Criteria:

• hemodynamic instability

• severe intracranial disease

• barotrauma

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Care
• Weaning

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil,