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

NCT06988111 | Recruiting

• 1 other identifier: 375690
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Weaning success

  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.

  At 48 hours and then daily for 28 days.

Study Arms (2)

Non-invasive Ventilation group

EXPERIMENTAL

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.

Device: BIPAP

High Velocity Nasal Cannula (HVNC) group

EXPERIMENTAL

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.

Device: Vapotherm

Interventions

BIPAP DEVICE

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

Non-invasive Ventilation group

Vapotherm DEVICE

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

Also known as: High-velocity nasal insufflation, High velocity nasal cannula

High Velocity Nasal Cannula (HVNC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit Univeristy

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ahmad M. Shaddad, MD

  Assuit Univeristy

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M. Shaddad, MD

CONTACT

+201111171930; shaddad_ahmad@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The patient with operative respiratory failure will be compared using NIV and High velocity nasal cannula devices

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6-36 months after publication.
• Access Criteria: Data will be accessible 6-36 months after publication to qualified researchers upon submission of a study proposal, approval by the University Research Ethics Committee, and execution of a data-use agreement.

Locations

EG (1)