Dokuz Eylul University School of Medicine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- PaCO2 values
Study Overview
Brief Summary
The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.
Detailed Description
Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.
This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.
Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.
Primary outcome; decrease in the PaCO2 values
Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PaCO2 > 45mmHg and any of the following
- •SaO2 <90% on air
- •SaO2 <93% on >6 Litres O2/min
- •Inability to speak in sentences due to respiratory distress
- •Respiratory rate > 24/min
- •Altered mental status
- •The use of accessory muscles of respiration
Exclusion Criteria
- •Respiratory arrest or unstable cardiorespiratory status
- •Suspected Pneumothorax
- •Urgent need for intubation
- •Systolic blood pressure < 90 mmHg
- •Inability to protect airway
- •Facial deformity
- •Facial, esophageal, or gastric surgery history
- •All trauma patients
- •Acute myocardial infarction
- •Severe arrythmias
- •Refractory nausea and vomiting
Arms & Interventions
BPAP ST/T
Non-invasive Ventilation with BPAP ST/T mode
Intervention: Noninvasive mechanical ventilation (Device)
AVAPS
Non-invasive Ventilation with AVAPS mode
Intervention: Noninvasive mechanical ventilation (Device)
Outcomes
Primary Outcomes
PaCO2 values
Time Frame: On arrival, at one hour, and at two hourly intervals thereafter
Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS
Secondary Outcomes
- Length of hospital stay(up to 6 months)
- Failure of treatment options(During the treatment)
- The time of treatment(During the treatment)
Investigators
Başak Bayram
Assistant Professor Dr.
Dokuz Eylul University