Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation

Mechanical Ventilation Clinical Trial

Official title:

In a Developing Country; What is the Fate of Hematologic Cancer Patients Requiring Mechanical Ventilation for More Than One Day? A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562105
• Other study ID #: 15.05.42
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: September 27, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.

Description:

It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Critical ill hematological cancer patient

• Requiring mechanical ventilation

Exclusion Criteria:

• Patients with acute coronary syndrome.

• Patients with cancer remission more than 5 years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Hematological Malignancy
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• Mechanical ventilation
requiring mechanical ventilation at admission to ICU for one day or more during the study period

Locations

Country	Name	City	State
Egypt	Mansoura Cancer Therapy Center	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Associated comorbidities	Like as sepsis, acute respiratory distress syndorme, or leukopenia	up to 24 hours after admission to the intensive care unit	Yes
Other	Cancer status	Early or advanced stage	up to 24 hours after admission to the intensive care unit	Yes
Primary	Survival	Continuing to live	through study completion, an average of 30 days after admission to intensive care unit	Yes
Secondary	Sequential Organ Failure Assessment score	Sequential Organ Failure Assessment (SOFA) Score	up to 24 hours after admission to the intensive care unit	Yes
Secondary	Simplified Acute Physiology Score II	Simplified Acute Physiology Score (SAPS II)	up to 24 hours after admission to the intensive care unit	Yes
Secondary	Mode of mechanical ventilation	synchronised intermittent, pressure-controlled, volume-controlled, pressure support, continuous positive airway pressure, volume guarantee, adjusted pressure release ventilation, or adaptive proportional assist ventilation	up to 24 hours after admission to the intensive care unit	No
Secondary	lowest Pa02/FiO2	PaO2 "arterial oxygen tension"/FiO2 "inspired fraction of oxygen" ratio	up to 24 hours after admission to the intensive care unit	Yes
Secondary	Reason for need of ventilatory support	Advanced malignancy, respiratory muscle weakness, respiratory failure, lung metastasis, coma, sepsis, multi-organs failure	up to 24 hours after admission to the intensive care unit	No