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Clinical Trials/CTRI/2020/05/025462
CTRI/2020/05/025462Not yet recruitingNot Applicable

Utility of Ultrasound-assessed diaphragmatic dysfunction in estimating non-invasive ventilation failure of patients with Acute exacerbation of chronic obstructive pulmonary disease

Not provided1 site in 1 country60 target enrollmentStarted: January 6, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Non-invasive ventilation (NIV) failure rate with respect to new onset or continuous diaphragmatic dysfunction assessed by ultrasound guided measurement of change in diaphragmatic thickness (ΔTDI).

Study Overview

Brief Summary

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is defined as an acute event characterized by a worsening of the patient’s respiratory symptoms. Noninvasive (NIV) is the first-line management in AECOPD. Diaphragmatic dysfunction (DD) is a common reason for dyspnoea in COPD. Ultrasound is a cheap, safe, non-invasive, less time consuming, bedside tool for detecting DD. Among various USG  parameters, change in the diaphragmatic thickness (ΔTDI) has been found to be the most sensitive parameter of DD. The aim of our study will be to assess the utility of ultrasound assessed DD (continuous and new-onset) in estimating the NIV failure of patients with AECOPD.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients with Acute exacerbation of chronic obstructive lung disease with acidosis (PaCO2 >45mm Hg, pH <7.25) in need of non-invasive ventilation.

Exclusion Criteria

  • •Patients with acute pulmonary edema.
  • •History of interstitial lung disease.
  • •History of neuromuscular disease.
  • •Chest wall deformities.
  • •Previously diagnosed diaphragmatic palsy.
  • •Hemodynamic instability (Systolic blood pressure <90 mm Hg).
  • •Intracranial hypertension.
  • •Any contraindication to Non-invasive ventilation,
  • •Need for immediate endotracheal intubation or invasive mechanical ventilation at ICU admission.

Outcomes

Primary Outcomes

Non-invasive ventilation (NIV) failure rate with respect to new onset or continuous diaphragmatic dysfunction assessed by ultrasound guided measurement of change in diaphragmatic thickness (ΔTDI).

Time Frame: ΔTDI assessed at 2 hrs on NIV or immediately prior to intubation if patient requires intubation before 2 hrs of NIV. | NIV failure assessed during ICU stay

Secondary Outcomes

  • Diaphragmatic dysfunction assessed by ultrasound guided measurement of change in diaphragmatic thickness (ΔTDI).(At ICU admission)
  • Time to NIV failure.(ICU admission (Day 1) to time point of intubation.)
  • Ventilation days (Non - invasive).(Duration of non-invasive ventilation)
  • Ventilation days (invasive).(Duration of invasive ventilation)
  • Length of stay in ICU.(ICU admission ( Day 1) to patients ICU discharge or death or 30 days whichever is earlier)
  • In hospital length of stay.(ICU admission (Day 1) to patient discharge or death or 30 days whichever is earlier.)
  • ICU mortality, In hospital mortality and 30 day mortality.(ICU admission (Day 1) to 30 days follow up or death whichever is earlier.)

Investigators

Sponsor
Not provided

Study Sites (1)

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