Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Completed

• Conditions: Respiratory Distress Syndrome, Adult; Ventilator-Induced Lung Injury

• Registration Number: NCT02732041
• Lead Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

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.

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 Timeline

• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Study Start: 2016-05-25
• Primary Completion: 2018-11-22
• Study Completion: 2019-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asynchrony rate	30 minutes	Asynchronies per minutes of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (5)

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, Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas); 🇦🇷 Caba, Argentina