NCT05741697

Brief Summary

Patients with Bronchiectasis experience exacerbations with hypercapnic respiratory failure associated with an increased respiratory workload that may require intensive care unit (ICU) admission due to the inability of the respiratory muscles to compensate for increased demand. These exacerbations are frequently treated with noninvasive ventilation (NIV).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Mar 2023Oct 2026

First Submitted

Initial submission to the registry

February 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

February 12, 2023

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of efficacy and patient compliance of high flow nasal canula system in comparison to Noninvasive mechanical ventilation in management of acute exacerbation of Bronchiectasis

    The duration of ICU admission days and the patient compliance to both devices will be compared.

    March 2023 to December 2023

Study Arms (2)

Patient need NIV ventillation

Patients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need NIV

Drug: bi-level ventillation

patient need HFNC

Patients will be eligible for enrolment if they are diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU); requiring ventilator support without invasive mechanical ventilation and will need HFNC

Interventions

non-invasive mechanical ventilation

Also known as: HFNC
Patient need NIV ventillation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.

You may qualify if:

  • Patients will be eligible for enrolment if diagnosed with bronchiectasis and admitted to the respiratory intensive care unit (RICU), requiring ventilator support without invasive mechanical ventilation.

You may not qualify if:

  • Age: less than 18 years. Patients with post-arrest encephalopathy. Patient with the previous tracheotomy. Patients who received invasive ventilatory support. Patients with end-organ failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University-Faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Ahmad M. Shaddad

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmad shaddad, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pulmonology

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 23, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations