NCT03169452

Brief Summary

Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the intensive care unit. Noninvasive ventilation is further subdivided into negative pressure ventilation which is the iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to provide negative pressure during inspiration and positive pressure during expiration. Noninvasive positive pressure ventilation can be used as continuous positive airway pressure or bi-level positive airway pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

May 25, 2017

Last Update Submit

June 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of patients need mechanical ventilation

    the number of patients without improvement on non-invasive ventilator and require transfer to mechanical ventilator

    1-48 hours

Interventions

mechanical assisted breaths without the placement of an artificial way

Also known as: continuous positive airway pressure

Eligibility Criteria

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

All patients who admitted to the Respiratory intensive care unit and the attending team conducted him to Non invasive ventilation

You may qualify if:

  • obstructive sleep apnea syndrome
  • acute exacerbation Chronic obstructive pulmonary disease
  • pneumonia
  • interstitial lung diseases

You may not qualify if:

  • Patients refuse Non invasive ventilation
  • Patients with absolute indication for Mechanical ventilator (in respiratory arrest or unstable cardiorespiratory status, trauma or burns involving the face, or gastric surgery, reduced consciousness, Pneumothorax
  • Patients with contraindication to Non invasive ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Sahar Mohamed, MBBCh

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

July 3, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations