Noninvasive Ventilation Weaning Protocol in COPD

NCT07133711 | Completed DMC

• 1 other identifier: WGEK-NIV-Weaning-Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Noninvasive ventilation (NIV) has revolutionized the management of patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with hypercapnic respiratory failure (HcRF). NIV use has been shown to reduce the need for endotracheal intubation, hospital and intensive care unit (ICU) length of stay, and mortality. Multiple studies have been conducted on weaning strategies among patients requiring invasive mechanical ventilation. As a result of these studies, definite criteria and protocols have been laid down for weaning from invasive mechanical ventilation. However, no such data are available for the withdrawal of NIV. Evidence-based reviews suggest that protocols to manage the weaning and liberation of subjects from Mechanical Ventilation could reduce the time that subjects spend receiving mechanical ventilation. However, no such data about protocolized withdrawal of NIV are available.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Noninvasive ventilation; Weaning

Outcome Measures

Primary Outcomes (1)

• Successful weaning

  The primary objective of the study is to compare the rate of successful withdrawal of NIV among the three groups.

  48 hours

Study Arms (3)

Gradual PS Decrement

EXPERIMENTAL

): pressure support will be reduced by 2-4 cm H2O every 6-8 h with vitals and blood gas monitoring till IPAP of \<8 cm of H2O and EPAP of \<4 cm of H2O is attained, after which NIV will be completely withdrawn

Device: Noninvasive ventilation

Gradual Time Decrement

EXPERIMENTAL

the duration of NIV will be reduced to 16 h on the day of randomization (day 0), then reduced to 12 h on day 1 (including 6-8 h of overnight use), 6-8 h of overnight use on day 2, and complete withdrawal on day 3.

Device: Noninvasive ventilation

Abrupt Withdrawal

ACTIVE COMPARATOR

patients will be immediately withdrawn from NIV and monitored on spontaneous breathing.

Device: Noninvasive ventilation

Interventions

Noninvasive ventilation DEVICE

Weaning from noninvasive ventilation for patients with acute exacerbation of COPD

Abrupt Withdrawal; Gradual PS Decrement; Gradual Time Decrement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age: less than 18 years,
• End organ failure as cardiac/ Liver/ Renal,
• Patients on home NIV and
• Those who required NIV for respiratory failure due to diseases other than COPD were not considered for the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

Location

Related Publications (3)

• Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.

  PMID: 26976648 BACKGROUND

• Lun CT, Chan VL, Leung WS, Cheung AP, Cheng SL, Tsui MS, Chu CM. A pilot randomized study comparing two methods of non-invasive ventilation withdrawal after acute respiratory failure in chronic obstructive pulmonary disease. Respirology. 2013 Jul;18(5):814-9. doi: 10.1111/resp.12080.

  PMID: 23490403 BACKGROUND

• Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

  PMID: 7921460 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• waleed gamal elddin, ass. prof

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and clinical staff managing the weaning will not be blinded to group assignment. However, outcome assessors \[the physician adjudicating weaning success based on predefined criteria\] and data analysts will be blinded to group allocation throughout the outcome assessment and analysis phases
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of chest diseases

Model Details: Each participant is assigned to only one of the three intervention groups (gradual pressure support decrement, gradual time spent on noninvasive per day decrement, abrupt withdrawal of noninvasive ventilatory support) for the entire duration of the weaning period.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)