NCT03296215

Brief Summary

Human health comprises many different states, ranging from perfect health to critical illness, so medical facilities should be able to provide medical assistance tailored to the patient's degree of disease. The Intensive Care Unit (ICU) serves as a place for monitoring and care of patients with potentially severe physiologic instability requiring technical and/or artificial life support. The level of care in an ICU is greater than that available on the floor or Intermediate Care Unit. Because of the utilization of expensive resources, ICUs should, in general, be reserved for those patients with reversible medical conditions who have a "reasonable prospect of substantial recovery". About one third of hospital mortality occurs in critically ill patients in the intensive care unit. On the other hand, critically ill patients are responsible for 10 - 20 % of global hospital costs. It is well accepted that early appropriate referral of patients to an ICU can significantly reduce early and possibly late mortality in the critically ill.At the same time improper selection of patients for ICU who block ICU beds often limits bed availability in ICUs. This in turn adversely affects the dynamics the whole hospital. The Respiratory Intensive Care Unit (RICU) is an area that provides closed monitoring and intensive treatment for patients with acute or exacerbated respiratory failure caused by a disease that is primarily respiratory.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

September 9, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 9, 2017

Last Update Submit

September 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The purpose of study is determine prognosis of patients admitted in Respiratory Intensive Care Unit at Assiut University Hospitals.

    Assessment of Acute Physiology and Health Evaluation II (APHCHE II) score of each admitted case.

    First 24hours of admission.

Study Arms (1)

Observational

Patterno of admitted cases in Respiratory Intensive Care Unit at Assiut University Hospitals and Outcome

Other: Observational

Interventions

To determine different patterns of admission and their Outcome

Observational

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Only patients admitted to repiratory ICU

You may qualify if:

  • Patients with the following conditions are candidates for admission to the respiratory Intensive Care Unit. The following conditions include, but are not limited to:
  • Acute respiratory failure requiring ventilatory support
  • Acute pulmonary embolism with haemodynamic instability
  • Massive haemoptysis
  • Upper airway obstruction

You may not qualify if:

  • Patients who are generally not appropriate for respiratory ICU admission:
  • Irreversible brain damage
  • End stage cardiac, respiratory and liver disease with no options for transplant
  • Metastatic cancer unresponsive to chemotherapy and/or radiotherapy
  • Patients with non-traumatic coma leading to a persistent vegetative state (7,8,9,10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kahn JM, Goss CH, Heagerty PJ, Kramer AA, O'Brien CR, Rubenfeld GD. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med. 2006 Jul 6;355(1):41-50. doi: 10.1056/NEJMsa053993.

    PMID: 16822995BACKGROUND

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Mahmoud Badwy, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Yousef Ahmad, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Badwy, Resident

CONTACT

Yousef Ahmad, Prof

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 9, 2017

First Posted

September 28, 2017

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

March 1, 2020

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Individual participant data will be available for primary Outcome

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 6 months from study completion
Access Criteria
Data access will be reviewed by internal independent review panel