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

NCT ID: NCT02687802

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-10
• Study Completion Date: 2019-03-31

Brief 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.

Detailed 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

Conditions

Respiratory Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mechanical ventilation

Patients under mechanical ventilation for more than 24h

mechanical ventilation

Intervention Type: OTHER

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

Interventions

mechanical ventilation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana C Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Locations

Hospital das Clínicas -HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21.

Reference Type: DERIVED

PMID: 32032901 (View on PubMed)

Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. EPISYNC study: predictors of patient-ventilator asynchrony in a prospective cohort of patients under invasive mechanical ventilation - study protocol. BMJ Open. 2019 May 22;9(5):e028601. doi: 10.1136/bmjopen-2018-028601.

Reference Type: DERIVED

PMID: 31123002 (View on PubMed)

Other Identifiers

2015/19122-4

Identifier Type: -

Identifier Source: org_study_id