NCT03230617

Brief Summary

Chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. Severe airflow obstruction that imposes a significant load on the respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The reduced expiratory airflow also causes air trapping at the end of expiration , producing alveolar pressure that are higher than atmospheric pressure before the next breath. This condition is intrinsic positive end-expiratory 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

July 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 24, 2017

Last Update Submit

July 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The duration of mechanical ventilation

    1 month

Study Arms (2)

Intrinsic positive end expiratory pressure > 5

chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure more than5

Device: Mechanical ventilator

Auto positive end expiratory pressure < 5

chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure less than5

Device: Mechanical ventilator

Interventions

Mechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing.

Auto positive end expiratory pressure < 5Intrinsic positive end expiratory pressure > 5

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient who diagnosed as chronic obstructive pulmonary disease admitted to the respiratory intensive care unit, chest department, Assiut university hospital, who are mechanically ventilated.

You may qualify if:

  • patient with acute exacerbation of Chronic obstructive pulmonary disease and respiratory failure who are intubated and mechanically ventilated.

You may not qualify if:

  • patient with neuromuscular diseases.
  • patient with pulmonary vascular diseases e.g pulmonary embolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.

    PMID: 16438005BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Suzan Salama, MSc

CONTACT

Aliae Abd Rabou, MD

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

July 24, 2017

First Posted

July 26, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 31, 2018

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations