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

NCT02687802 | Completed

• 1 other identifier: 2015/19122-4
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Keywords

respiratory mechanics; Respiratory Insufficiency; artificial, ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical signs of patient-ventilator asynchrony

  daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days

• ventilation free-days

  28 days

• tracheostomy rate

  up to 90 days

• Survival rate

  at 28 and 90 days

Study Arms (1)

Mechanical ventilation

Patients under mechanical ventilation for more than 24h

Other: mechanical ventilation

Interventions

mechanical ventilation OTHER

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

Mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients intubated and under invasive mechanical ventilation in a University hospital ICU

You may qualify if:

• Recent mechanical ventilation (less than 72 hours)
• Expectation of mechanical ventilation for more than 24 hours
• Age ≥ 18 years old

You may not qualify if:

• High flow Bronchopleural fistula
• Thoracic or abdominal deformities that could compromise the accuracy of respiratory mechanics measurement
• Impossibility to measure respiratory mechanics
• Tracheostomy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas -HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32032901 DERIVED

• 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.

  PMID: 31123002 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Juliana C Ferreira, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 22, 2016
• Study Start: September 10, 2016
• Primary Completion: January 1, 2019
• Study Completion: March 31, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)