Clinical trial NCT01065428: Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure
Official title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China; Department of Critical Care Medicine St. Michaels's Hospital, University of Toronto, Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: neuromechanical efficiency
neuroventilatory efficiency
weaning
Respiration, Artificial
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2010-02-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who required mechanical ventilation for more than 24 h.

Brief summary: The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully extubated and those who failed weaning.

Detailed description: Patients, mechanically ventilated for \> 24 h, were included when they met criteria for their first spontaneous breathing trial (SBT) on continuous positive airway pressure (CPAP) (5-6 cmH2O) for 30 minutes. Patients who did not fulfill the criteria for successful SBT, or required assist, or deceased within 48h post-extubation were considered extubation failure (F). Patients who completed the SBT and remained extubated \> 48 h were considered successfully extubated (S). Before and during the SBT, arterial blood gases, heart, rate, blood pressure, and EAdi, flow, Vt, f, and, airway pressure (Paw) were measured. At 0, 5, 10, 15 and 30 minutes of the SBT, f/Vt, diaphragm electrical activity (EAdi), NME, and NVE were calculated. NME was calculated as Paw/EAdi during inspiratory occlusion. NVE was calculated as Vt/EAdi during unassisted inspirations.Arterial blood gases, heart rate, and blood pressure were measured. The receiver operating characteristic (ROC) curve was calculated to evaluate the predictive performance of each index.

Eligibility criteria: Inclusion Criteria:

* We chose a number of eligible patients which were admitted to ICU of the Zhong-Da Hospital and required mechanical ventilation for more than 24 h.

Exclusion Criteria:

(1) age \<18 or \>85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (INR ratio\>1.5 and APTT\>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor

Primary outcomes:
measure: Neuroventilatory Efficiency (NVE)
timeFrame: at 30 minutes of the spontaneous breathing trials (SBT)
Secondary outcomes:
measure: Neuromechanical Efficiency (NME)
timeFrame: at 30 minutes of the spontaneous breathing trials (SBT)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Haibo Qiu, MD, Phd
role: STUDY_DIRECTOR
References:
citation: Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451.