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Completed

NCT Number: NCT07133711

Noninvasive Ventilation Weaning Protocol in COPD

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University hospital

Asyut, 71515, Egypt

About this study

A study to compare protocolized weaning from non-invasive ventilation using three potential strategies of weaning from NIV

  • Stepwise reduction of duration of NIV use,
  • Stepwise reduction in pressure support of NIV, and
  • Immediate withdrawal of NIV. Among patients with Acute respiratory failure due to acute exacerbation of COPD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All COPD patients admitted in the respiratory ICU with acute Hypercapnic Respiratory Failure who will be managed with Noninvasive Ventilation without the need for invasive mechanical ventilation will be eligible for inclusion in the study.

Exclusion criteria

  • 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.

Treatment and study plan

Noninvasive Ventilation

Device

Weaning from noninvasive ventilation for patients with acute exacerbation of COPD

Primary outcomes

  1. Successful weaning

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Noninvasive Ventilation Weaning Protocol on Outcome of Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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