Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)

Not Applicable

Not yet recruiting

• Conditions: Respiratory Failure Without Hypercapnia; Respiratory Failure With Hypercapnia; Postoperative Respiratory Complication

• Registration Number: NCT06988111
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

• Age below 18 years
• Pregnant ladies
• Orofacial trauma or burns
• Active Gastrointestinal bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weaning success	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.

Trial Locations

Locations (1)

Assuit Univeristy; 🇪🇬 Asyut, Assuit, Egypt