CPAP Versus NPPV in ACPE | NCT00446498

Studies
CPAP Versus NPPV in ACPE

NCT00446498

Sponsor

Ospedale S. Giovanni Bosco

Status

Completed

Last Update Posted

Apr 3, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Pulmonary Edema

Interventions

CPAP and Non Invasive Ventilation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

May 2005Actual

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2007

Last Update Posted Date

Apr 3, 2007Estimated

Description Module

Brief Summary

To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.

Detailed Description

Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.

Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.

Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.

Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.

Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
CPAP and Non Invasive Ventilation	Device

Measure	Description	Time Frame
Intubation rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rapid onset of the symptoms
severe dyspnoea at rest
respiratory rate > 30 breath per minute
use of accessory respiratory muscles
PaO2/FiO2 < 200, radiological findings of ACPE

Exclusion Criteria:

ST elevation myocardial infarction
hemodynamic instability (systolic arterial pressure < 90 mmHg
need for immediate endotracheal intubation (respiratory arrest, bradypnea
inability to protect the airways, impaired sensorium (agitation or unconsciousness
inability to clear secretions, respiratory tract infections
chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
gastrointestinal bleeding
facial deformities
haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanni Ferrari, MD	Ospedale San Giovanni Bosco ASL4	Principal Investigator
Giovanni Ferrari, MD	Ospedale San Giovanni Bosco ASL4 Torino Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Giovanni Bosco Medicina d'Urgenza		Torino		10154	Italy

ID	Term
D011654	Pulmonary Edema

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
time of recovery
hospital length of stay
mortality and improvement in gas exchange