NCT00507533

Brief Summary

The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

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

October 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

2.1 years

First QC Date

July 25, 2007

Last Update Submit

February 17, 2009

Conditions

Hematologic Disease

Keywords

CPAPHematologicNeutropenicARF

Outcome Measures

Primary Outcomes (1)

  • mechanical ventilation and intubation

Secondary Outcomes (1)

  • Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality

Interventions

Continuous positive airway pressurePROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .
  • SaO2 less than 95% ( a.a.) ,
  • Respiratory rate (RR ) more than 25 breaths/minute .

You may not qualify if:

  • NYHA class II- III- IV or unstable angina or MI
  • Valvular heart disease or cardiac surgery ( previous 3 months)
  • Implanted cardiac pacemaker
  • BMI less than 40
  • History of dilated cardiomyopathy or CPE
  • Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , FEV1 \< 50 %)
  • Diagnosis of sleep or neuromuscular disorders.
  • Claustrophobia .
  • Mechanical ventilation criteria:
  • Severe hypoxemia (arterial oxygen saturation \< 80 % with maximal FiO2 )
  • Ph \< 7.3 with a PaCO2 \> 50 mmHg
  • Signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement
  • RR \> 35 breaths/minute .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi Torino

Turin, Piedmont, 10100, Italy

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Squadrone Vincenzo, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

October 1, 2005

Primary Completion

November 1, 2007

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

IT(1)