Asynchronies During Mechanical Ventilation

NCT03451461 | Completed

• 1 other identifier: Asynchronies
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Mechanical Ventilation Complication

Keywords

Asynchronies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Influence of sedation and analgesia in the incidence of asynchronies

  during all period of mechanical ventilation up to the study end, approximately december 2018

• Influence of respiratory mechanics in the incidence of asynchronies

  during all period of mechanical ventilation up to the study end, approximately december 2018

Interventions

No intervention OTHER

Observational study. Clinical data recorded

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (4)

Candelaria de Haro

Sabadell, Barcelona, 08208, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Fundació Althaia

Manresa, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Related Publications (2)

• 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.

  PMID: 35120043 DERIVED

• 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.

  PMID: 31277722 DERIVED

Study Officials

• Lluis Blanch, PhD

  Director of Institut Parc Tauli

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 1, 2018
• Study Start: January 1, 2011
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

ES (4)