NCT04735497

Brief Summary

Patient ventilator asynchrony is a common problem in mechanically ventilated patients .It is associated with adverse effects including increased work of breathing, patient discomfort, increased need for sedation, prolonged mechanical ventilation , weaning difficulties and weaning failure. 100 mechanically ventilated COPD patients were enrolled in this prospective study .Detection of patient ventilator asynchrony was done on 30-minute sessions at 12, 24, 36, and 48 hours following intubation by visual assessment of pressure, flow and volume graphs on ventilator .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

January 11, 2021

Last Update Submit

February 9, 2021

Conditions

Keywords

mechanically ventilatedweaning failureCOPDasynchrony

Outcome Measures

Primary Outcomes (1)

  • To study effect of different types of ventilator asynchrony on weaning in mechanically ventilated COPD patients

    Detection of patient ventilator asynchrony was done on 30-minute sessions following intubation by visual assessment of pressure, flow and volume graphs on ventilator .Repeated measures are done from the begining of mechanical ventilation and type of asynchronies including ineffective trigger double trigger, auto trigger , delayed cycle, early cycle and flow asynchrony. were recorded.

    One year

Study Arms (2)

Failed Weaning

Patients who failed to be liberated from mechanical ventillation

Successful Weaning

Patients who were liberated from mechanical ventillation and needed no respiratory support

Eligibility Criteria

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

All COPD patients who were diagnosed after history ,physical examination ,radiology and pulmonary function tests and required mechanical ventilation.

You may qualify if:

  • All COPD patients who were diagnosed after history ,physical examination radiology and pulmonary function tests and required mechanical ventilation.

You may not qualify if:

  • Age \< 18 years
  • Tracheostomy
  • Failure to trigger breaths even in cases of receiving neuromuscular blocking agents.
  • Encephalopathy which is not caused by hypercapnia or hypoxemia either post arrest or due to cerebrovascular stroke
  • Patients with unplanned weaning
  • COPD patients where intubation not related to exacerbation e.g. acute pulmonary edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Samiaa Sadek, Ass.Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 11, 2021

First Posted

February 3, 2021

Study Start

February 15, 2018

Primary Completion

August 15, 2019

Study Completion

December 20, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations