Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno (Other)

Overall Status

Completed

CT.gov ID

NCT02732041

Collaborator

(none)

103

Enrollment

Locations

32.3

Actual Duration (Months)

20.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult Ventilator-Induced Lung Injury

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

103 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Actual Study Start Date :

May 25, 2016

Actual Primary Completion Date :

Nov 22, 2018

Actual Study Completion Date :

Feb 1, 2019

Outcome Measures

Primary Outcome Measures

Asynchrony rate [30 minutes]
Asynchronies per minutes of mechanical ventilation

Secondary Outcome Measures

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]
ICU mortality [From the date of admission to the date of discharge from the ICU, up to 90 days]
Hospital mortality [From the date of admission to the date of discharge from the ICU, up to 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complejo Medico Churruca Visca	Ciudad Autonoma Buenos Aires	Buenos Aires	Argentina
2	Hospital Italiano de Buenos Aires	Ciudad Autonoma Buenos Aires	Buenos Aires	Argentina
3	Sanatorio Anchorena	Ciudad Autonoma Buenos Aires	Buenos Aires	Argentina
4	Sanatorio La Trinidad Mitre	Ciudad Autonoma Buenos Aires	Buenos Aires	Argentina
5	CEMIC (Centro de Educación Médica e Investigaciones Clínicas)	Caba		Argentina	1431