Clinical trial NCT06988111: Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
Official title: A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure Without Hypercapnia
Respiratory Failure With Hypercapnia
Postoperative Respiratory Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patient with operative respiratory failure will be compared using NIV and High velocity nasal cannula devices
Primary purpose: SUPPORTIVE_CARE

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.

- Escalation Criteria The patient exhibits persistent partial arterial oxygen pressure/fraction of inspired oxygen ratio (PaO2/FiO2) levels of less than 100, even at maximal settings.

Hemodynamic instability occurs due to the use of new-onset vasopressors. Deterioration leading to invasive ventilation → classified as "reintubation."

* Weaning Protocol. Transition to standard oxygen therapy when the flow or pressure is minimal.
* Follow-Up \& Discharge Track ICU length of stay (LOS), hospital LOS, and ventilation-free days (VFD). Keep a record of the 30-day survival rate and any readmissions.
* Statistical Analysis Plan Primary Endpoint: Compare reintubation rates using a χ² test; report the risk difference and 95% confidence interval.
* Missing Data: Multiple imputation for datasets with ≤ 5% missing data; sensitivity analysis for worst-case scenarios.
* Interim Analysis: After 50% enrollment, the Data Safety and Monitoring Board (DSMB) reviews efficacy and futility, using O'Brien-Fleming boundaries.

Eligibility criteria: 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

Primary outcomes:
measure: Weaning success
timeFrame: At 48 hours and then daily for 28 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assuit Univeristy
state: Assuit
Study officials:
affiliation: Assuit Univeristy
name: Ahmad M. Shaddad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Aliae A. Hussien, MD
role: PRINCIPAL_INVESTIGATOR
References: