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

NCT ID: NCT06988111

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

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.

Conditions

Respiratory Failure Without Hypercapnia; Respiratory Failure With Hypercapnia; Postoperative Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BIPAP

Intervention Type: DEVICE

The second arm (NIV group) will be managed by BIPAP device for post-operative respiratory failure

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.

Group Type: EXPERIMENTAL

Vapotherm

Intervention Type: DEVICE

The first arm (HVNC group) will be managed by Vapotherm device for post-operative respiratory failure

Interventions

BIPAP

The second arm (NIV group) will be managed by BIPAP device for post-operative respiratory failure

Intervention Type: DEVICE

Vapotherm

The first arm (HVNC group) will be managed by Vapotherm device for post-operative respiratory failure

Intervention Type: DEVICE

Other Intervention Names

High-velocity nasal insufflation; High velocity nasal cannula

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Shaddad

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad M. Shaddad, MD

Role: PRINCIPAL_INVESTIGATOR

Assuit Univeristy

Aliae A. Hussien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assuit Univeristy

Asyut, Assuit, Egypt

Countries

Egypt

Central Contacts

Ahmad M. Shaddad, MD

Role: CONTACT

shaddad_ahmad@aun.edu.eg

+201111171930

Facility Contacts

ahmed M. shaddad, MD

Role: primary

shaddad_ahmad@yahoo.com

+201111171930

Role: backup

shaddad_ahmad@yahoo.com

Other Identifiers

375690

Identifier Type: -

Identifier Source: org_study_id