Asynchronies During Mechanical Ventilation

Asynchronies During Mechanical Ventilation: Factors Related

Invasive mechanical ventilation (IMV) is a life support treatment for patients with acute respiratory failure. The IMV can generate adverse effects that may cause alterations in other organs besides the lung, creating an important problem during ICU stay, hospital stay and years after discharge. These consequences on morbidity and mortality have significant economic and social weight. In the United States the IMV represents 2.7 episodes per 1000 habitants, with an estimated cost of $27,000 million, representing 12% of all hospital expenses. The overall mortality in patients with IMV is 30-35%, increasing with age. Therefore, patients receiving IMV are a high-risk population and with higher costs.

A poor interaction between patient and ventilator during IMV can develop asynchronies. The asynchronies may present in 25% of patients. The majority of studies in ICU patients are limited to a evaluation of short periods of time. Asynchronies identification needs the application of respiratory physiology knowledge and the interpretation of respiratory signals from the ventilator waves. This allows identifying in an easy way different situations of "fight", but it also difficult the identification of situation where asynchronies are less obvious, doing that them remain underdiagnosed. Moreover, asynchronies can be only evaluated during a brief period of time, and it's difficult to know their incidence during all the IMV period and to make adjustments to improve them.

In our centre, it has been developed a continuous monitoring system during IMV which integrates, in real-time, all the information derived from digital monitors and ventilators. It allows a continuous and automatic detection of different events (through an intelligent alarm system) and quantification of asynchronies. It was demonstrated that asynchronies are frequent, that it can be present from the beginning of IMV, that it increase in severe patients under deep sedation and it can increase ICU and hospital mortality.

The investigators can study different factors that can influence over asynchronies development or can improve them.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Other: No intervention

Detailed Description

The aim of this study is to analyze the real incidence of asynchronies of patients undergoing mechanical ventilation and to analyze what factors may have an association with their appearance.

This factors includes factors related with the pulmonary mechanics of each patient and other factors such as the treatment administered, especially drugs with sedative and analgesic effect will be taken into account.

This can help to implement strategies for the improvement of asynchronies.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain
    • Hospital Virgen de las Nieves
  • Manresa, Spain
    • Fundacio Althaia
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Candelaria De Haro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU under mechanical ventilation and monitorized with the Better Care System.

Description

Inclusion Criteria:

• Mechanical ventilation more than 48 hours.
• Included during the first 24 hours of mechanical ventilation.

Exclusion Criteria:

• Less than 18 years old
• Pregnant patients
• Do-not-resuscitate orders
• Admitted for organ donation
• Chest tubes with suspected bronchopleural fistula.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of asynchronies during mechanical ventilation	Data will be collected through the middleware Better Care, an automatic system of asynchronies detection	during all period of mechanical ventilation up to the study end, approximately december 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of sedation and analgesia in the incidence of asynchronies	percentage of asynchronies (double cycling, ineffective efforts, short cycling, prolonged cycling, asynchrony index), dose in miligrams per kilogram daily of medication and type of medication administered daily. Medication data will be collected from the mediacal records daily.	during all period of mechanical ventilation up to the study end, approximately december 2018
Influence of respiratory mechanics in the incidence of asynchronies	percentage of asynchronies (doublé cycling, ineffective efforts, short cycling, prolonged cycling, asynchrony index, peak pressure in cmH2O, plateau pressure in cmH2O, flow liters/minute, peep in cmH2O, tidal volumen in mililiters, compliance in mililiters/cmH2O, resistances cmH2O/liters per second Respiratory emchanics data will be collected through the middleware Better Care	during all period of mechanical ventilation up to the study end, approximately december 2018

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Study Director: Lluis Blanch, PhD, Director of Institut Parc Tauli

Publications and helpful links

General Publications

• Magrans R, Ferreira F, Sarlabous L, Lopez-Aguilar J, Goma G, Fernandez-Gonzalo S, Navarra-Ventura G, Fernandez R, Montanya J, Kacmarek R, Rue M, Forne C, Blanch L, de Haro C, Aquino-Esperanza J; ASYNICU group. The Effect of Clusters of Double Triggering and Ineffective Efforts in Critically Ill Patients. Crit Care Med. 2022 Jul 1;50(7):e619-e629. doi: 10.1097/CCM.0000000000005471. Epub 2022 Feb 7.
• de Haro C, Magrans R, Lopez-Aguilar J, Montanya J, Lena E, Subira C, Fernandez-Gonzalo S, Goma G, Fernandez R, Albaiceta GM, Skrobik Y, Lucangelo U, Murias G, Ochagavia A, Kacmarek RM, Rue M, Blanch L; Asynchronies in the Intensive Care Unit (ASYNICU) Group. Effects of sedatives and opioids on trigger and cycling asynchronies throughout mechanical ventilation: an observational study in a large dataset from critically ill patients. Crit Care. 2019 Jul 5;23(1):245. doi: 10.1186/s13054-019-2531-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Asynchronies
• Other Study ID Numbers: Asynchronies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No