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Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01065428
Enrollment
52
Registered
2010-02-09
Start date
2008-12-31
Completion date
2010-07-31
Last updated
2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

neuromechanical efficiency, neuroventilatory efficiency, weaning, Respiration, Artificial

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.

Interventions

None listed

Sponsors

Unity Health Toronto
CollaboratorOTHER
Southeast University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neuroventilatory Efficiency (NVE)at 30 minutes of the spontaneous breathing trials (SBT)NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.

Secondary

MeasureTime frameDescription
Neuromechanical Efficiency (NME)at 30 minutes of the spontaneous breathing trials (SBT)NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).

Countries

China

Participant flow

Recruitment details

In a 20 beds general ICU of a teaching hospital, from December 2008 to May 2010, 52 patients , mechanically ventilated for \> 24 h, were included when they deemed ready for extubation by the clinical team and fulfilled established weaning criteria.

Pre-assignment details

Nasogastric tube Eligible patient was replaced with a modified EAdi catheter (Maquet, Solna, Sweden). Then the patients were switched to a Servo-i ventilator capable of processing signals of EAdi automatically.

Participants by arm

ArmCount
Weaning Failure
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
17
Weaning Successful
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
35
Total52

Baseline characteristics

CharacteristicWeaning SuccessfulWeaning FailureTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
22 Participants16 Participants38 Participants
Age, Categorical
Between 18 and 65 years
13 Participants1 Participants14 Participants
Age Continuous65.2 years
STANDARD_DEVIATION 18.5
76.0 years
STANDARD_DEVIATION 6.4
68.8 years
STANDARD_DEVIATION 16.4
Region of Enrollment
China
35 participants17 participants52 participants
Sex: Female, Male
Female
11 Participants9 Participants20 Participants
Sex: Female, Male
Male
24 Participants8 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 170 / 35
serious
Total, serious adverse events
0 / 170 / 35

Outcome results

Primary

Neuroventilatory Efficiency (NVE)

NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.

Time frame: at 30 minutes of the spontaneous breathing trials (SBT)

ArmMeasureValue (MEAN)Dispersion
Weaning FailureNeuroventilatory Efficiency (NVE)17.6 ml/uVStandard Deviation 10.7
Weaning SuccessfulNeuroventilatory Efficiency (NVE)39.9 ml/uVStandard Deviation 23.9
p-value: <0.05t-test, 2 sided
Secondary

Neuromechanical Efficiency (NME)

NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).

Time frame: at 30 minutes of the spontaneous breathing trials (SBT)

ArmMeasureValue (MEAN)Dispersion
Weaning FailureNeuromechanical Efficiency (NME)1.13 cmH2O/uVStandard Deviation 0.71
Weaning SuccessfulNeuromechanical Efficiency (NME)1.77 cmH2O/uVStandard Deviation 0.79
p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026