Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation

Respiratory Insufficiency Clinical Trial

— EpiSync  

Official title:

Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687802
• Other study ID #: 2015/19122-4
• Status: Completed
• Start date: September 10, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including patients under invasive mechanical ventilation. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously and quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge.

Description:

Patient-ventilator asynchrony is common in patients under invasive mechanical ventilation, present between 10 and 80% of all respiratory cycles, and is associated with adverse clinical outcomes, such as delay in the weaning process, increased complications of mechanical ventilation, with possible impact on survival. The objective of this study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including all patients under invasive mechanical ventilation admitted at Respiratory ICU at Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo (USP), during the study period. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously. The ventilator waveforms will be captured directly from ventilator and processed by dedicated software, without direct contact with patients. Later, ventilator waveforms will be analyzed to quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge, and the investigators will record duration of mechanical ventilation, the use of non-invasive ventilation post-extubation, reintubation, tracheostomy, ICU and hospital length of stay and survival. With this project, the investigators will estimate the incidence and magnitude of patient-ventilator asynchrony and its association with clinical outcomes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 31, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recent mechanical ventilation (less than 72 hours)

• Expectation of mechanical ventilation for more than 24 hours

• Age = 18 years old

Exclusion Criteria:

• High flow Bronchopleural fistula

• Thoracic or abdominal deformities that could compromise the accuracy of respiratory mechanics measurement

• Impossibility to measure respiratory mechanics

• Tracheostomy

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• mechanical ventilation
we will measure static resistance, compliance and intrinsic positive end-expiratory pressure (PEEP) and other variables as risk factors for asynchrony occurrence

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas -HCFMUSP	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asynchrony index	asynchrony index will be calculated as the number of major asynchrony events divided by total number of respiratory cycles	from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days
Secondary	Clinical signs of patient-ventilator asynchrony	a standardized questionnaire will be used to evaluate the presence of clinically significant patient-ventilator asynchrony. Trained investigators will observe participant´s breathing pattern and other clinical signs of patient-ventilator asynchrony and score each item as absent (0) or present (1). Then, they will visual inspection of ventilator waveforms on the ventilator screen for a 5 minute observation period, looking for missed efforts, double triggering, auto-triggering, cycling delay and premature cycling, as previously defined. If they observe more than 1 asynchrony event for every 10 respiratory cycles, they will rate this item as present (1), otherwise, they will rate it as absent (0).	daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days
Secondary	ventilation free-days	number of days alive and off the ventilator up to day 28	28 days
Secondary	tracheostomy rate	performance of surgical or bronchoscopy-guided tracheotomy	up to 90 days
Secondary	Survival rate	survival from intubation up to 90 days	at 28 and 90 days