Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732041
• Other study ID #: CEMIC1008
• Status: Completed
• Start date: May 25, 2016
• Est. completion date: February 2019

Study information

• Verified date: January 2020
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. The purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

Description:

Major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. Few studies have evaluated double cycling in ARDS patient. No clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. This study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. A blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. Clinical and outcome data will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2019
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Acute Respiratory Distress Syndrome according to Berlin definition

• Intubation and mechanical ventilation within 72 hours of inclusion

Exclusion Criteria:

• Known severe neuromuscular disease

• Continuous neuromuscular blocking agents infusion

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome
• Ventilator-Induced Lung Injury

Locations

Country	Name	City	State
Argentina	CEMIC (Centro de Educación Médica e Investigaciones Clínicas)	Caba
Argentina	Complejo Medico Churruca Visca	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Sanatorio Anchorena	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Sanatorio La Trinidad Mitre	Ciudad Autonoma Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony rate	Asynchronies per minutes of mechanical ventilation	30 minutes
Secondary	Length of mechanical ventilation		From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days
Secondary	ICU mortality		From the date of admission to the date of discharge from the ICU, up to 90 days
Secondary	Hospital mortality		From the date of admission to the date of discharge from the ICU, up to 90 days