Clinical trial NCT03451461: Asynchronies During Mechanical Ventilation
Official title: Asynchronies During Mechanical Ventilation: Factors Related
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Keywords: Asynchronies
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU under mechanical ventilation and monitorized with the Better Care System.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of asynchronies during mechanical ventilation
timeFrame: during all period of mechanical ventilation up to the study end, approximately december 2018
Secondary outcomes:
measure: Influence of sedation and analgesia in the incidence of asynchronies
timeFrame: during all period of mechanical ventilation up to the study end, approximately december 2018
measure: Influence of respiratory mechanics in the incidence of asynchronies
timeFrame: during all period of mechanical ventilation up to the study end, approximately december 2018
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Candelaria de Haro
state: Barcelona
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Manresa
country: Spain
facility: Fundació Althaia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
Study officials:
affiliation: Director of Institut Parc Tauli
name: Lluis Blanch, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.