A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Assiut University
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Weaning success
Study Overview
Brief Summary
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU) stays, and increased resource burden.
Detailed Description
Noninvasive ventilation (NIV) and high-flow nasal cannula (HFNC) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. However, head-to-head data in patients with obstructive or restrictive pulmonary function (PORF) are scarce.
This protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. We hypothesize that NIV will reduce 72-hour reintubation rates compared to HFNC, translating into shorter ICU stays and lower costs.
Methodology & Operational Workflow
- Screening & Consent Identify eligible patients in the post-anesthesia care unit (PACU) or ICU. Obtain informed consent from the patient or legal surrogate.
- Baseline Assessment The baseline assessment includes demographics, comorbidities, and surgical data, as well as baseline arterial blood gases (ABG), vital signs, and comfort scores.
- Randomization & Initiation Allocate via a secure web-based randomization module. Initiate assigned respiratory support within 30 minutes of notification.
- Monitoring & Data Collection The patient is receiving continuous pulse oximetry and respiratory rate monitoring.
ABGs and fraction of inspired oxygen (FIO2) at 1 hour, 6 hours, and 24 hours. Comfort scores every six hours. Record interface-related adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age above 18 years
- •within 48 hours after major surgery
- •PAO2/FIO2 less than 200
- •Signs of respiratory distress and respiratory rate (RR) more than 25 cycles/minute
Exclusion Criteria
- •Age below 18 years
- •Pregnant ladies
- •Orofacial trauma or burns
- •Active Gastrointestinal bleeding
Arms & Interventions
Non-invasive Ventilation group
NIV Arm
- Device: Bi-level positive airway pressure (BiPAP) via oronasal mask.
- Initial settings: inspiratory positive airway pressure (IPAP) 10 cmH₂O, expiratory positive airway pressure (EPAP) 5 cmH₂O, and fraction of inspired oxygen (FiO₂) titrated to oxygen saturation (SpO₂) ≥ 92%.
- Weaning: Decrement IPAP/EPAP by 2 cmH₂O every four hours as tolerated.
Intervention: BIPAP (Device)
High Velocity Nasal Cannula (HVNC) group
HVNC Arm
- Device: Heated, humidified high-flow nasal cannula (HFNC) system.
- Initial flow: 50 L/min, fraction of inspired oxygen (FiO₂) titrated to SpO₂ ≥ 92%.
- Weaning: Reduce flow by 10 L/min every 4 h as tolerated.
Intervention: Vapotherm (Device)
Outcomes
Primary Outcomes
Weaning success
Time Frame: At 48 hours and then daily for 28 days.
The primary outcome will be comparing the weaning success (in days) for both arms of the study group. This will be accessed after 48 hours and on a daily basis until the weaning criteria are met or for 28 days.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmad Shaddad
Associate Professor
Assiut University