NCT03253380

Brief Summary

this study aim to compare the effect of early rehabilitation program on mechanical ventilated COPD patient in Respiratory ICU to those using current standard care as regarding :

  • morbidity and thirty day mortality
  • diaphragm function and weaning outcomes.
  • disease exacerbation
  • Duration spent on ventilator.
  • Length of ICU stay

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

August 10, 2017

Last Update Submit

August 17, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Measure thirty day mortality rate among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

    measure the percentage of patients who die within 30 days after mechanical ventilation

    2 years

  • Measure disease exacerbation among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

    measure number of exacerbations in COPD patients during six months after weaning from mechanical ventilation

    2 years

  • Measure duration spent on ventilator among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

    measure duration of mechanical ventilation

    2 years

  • Measure duration of ICU stay among COPD patients who was subjected to early rehabilitation program during mechanical ventilation in RICU and those using current standard care

    measure duration of ICU stay

    2 years

Study Arms (1)

early rehabilitation program on mechanical ventilated COPD pat

EXPERIMENTAL

compare the effect of early rehabilitation program on mechanical ventilated COPD patient in RICU to those using current standard care as regarding (morbidity and thirty day mortality ,diaphragm function and weaning outcomes, disease exacerbation , Duration spent on machin , Length of ICU stay.

Other: Early Rehabilitation Program In Critically Ill Chronic Obstructed Airway Disease patients

Interventions

Early rehabilitation of MV patients in the respiratory ICU

early rehabilitation program on mechanical ventilated COPD pat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All COPD patients admitted to ICU are aged more than 18 years are haemodynamically stable and requiring minimal ventilatory support (ie positive end expiratory pressure (PEEP) less than or equal100.

You may not qualify if:

  • medically unstable (eg, new cardiac arrhythmia , heamodynamic unstable)
  • experiencing significant pain that interferes with breathing capacities, fractured ribs
  • have major disorders which affect the central nervous system resulting in permanent weakness that is not responsive to exercise training
  • COPD patient with neuromuscular disease or overlap with OSA (obstructive sleep apnea).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 17, 2017

Study Start

September 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 22, 2017

Record last verified: 2017-08