Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

NCT00912158 | Completed Phase 4 Results

• 1 other identifier: RICU, Assiut University 1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.

Conditions

Acute Cardiogenic Pulmonary Edema

Keywords

CPE; CPAP; BiPAP; non invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Were Intubated

  Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation

  During ICU Stay

Secondary Outcomes (1)

• Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality

  Hospital stay

Study Arms (3)

CPAP + ST

ACTIVE COMPARATOR

Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)

Device: CPAP

BiPAP + ST

ACTIVE COMPARATOR

Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)

Device: BIPAP

ST

ACTIVE COMPARATOR

Standard Medical therapy (ST)

Other: standard therapy (ST)

Interventions

standard therapy (ST) OTHER

standard medical therapy

Also known as: Medical treatment of acute cardiogenic pulmonary oedema

ST

CPAP DEVICE

Non-invasive mechanical ventilation (CPAP)

Also known as: Continuous postive air way pressure, noninvasive positive support ventilation (NPSV)

CPAP + ST

BIPAP DEVICE

Non-invasive mechanical ventilation (BIPAP)

Also known as: Bilevel Positive Airway Pressure ventilation

BiPAP + ST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CPE confirmed radiologically and/or clinically
• Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
• Dyspnea of sudden onset with respiratory
• Systolic blood pressure \< 180 mmHg

You may not qualify if:

• Immediate need for endotracheal intubation:
• Severe sensorial impairment
• Shock
• Ventricular arrhythmias,
• Life-threatening hypoxia (SpO2 \[oxygen saturation as indicated by pulse oximetry\] less than 80% with oxygen)
• Acute myocardial infarction necessitating thrombolysis
• Cardiac or respiratory arrest
• Severe chronic renal failure
• Pneumothorax.
• Contraindication of non invasive ventilation (NIV)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71111, Egypt

Location

Related Publications (4)

• Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Crit Care Med. 2002 Nov;30(11):2457-61. doi: 10.1097/00003246-200211000-00009.

  PMID: 12441754 BACKGROUND

• Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J; 3CPO Trialists. Noninvasive ventilation in acute cardiogenic pulmonary edema. N Engl J Med. 2008 Jul 10;359(2):142-51. doi: 10.1056/NEJMoa0707992.

  PMID: 18614781 BACKGROUND

• Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Non-invasive ventilation in acute cardiogenic pulmonary oedema. Postgrad Med J. 2005 Oct;81(960):637-43. doi: 10.1136/pgmj.2004.031229.

  PMID: 16210459 BACKGROUND

• Vital FM, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE, Atallah AN. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005351. doi: 10.1002/14651858.CD005351.pub2.

  PMID: 18646124 RESULT

Related Links

• Medscape: Free CME, Medical News, Full-text Journal Articles \& More
• U.S. National Library of Medicine \& the National Institutes of Health
• The Cochrane library: Evidence for healthcare decision-making

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Maha K Ghanem, MD, FCCP
• Organization: Chest Department, Faculty of Medicine, Assiut University- EGYPT

mahaghanem@hotmail.com

+ 2 0127694434

Study Officials

• Gamal M Agmy, MD, FCCP

  Chest Department, Faculty of Medicine-Assiut University

  PRINCIPAL INVESTIGATOR

• Maha K Ghanem, MD

  Chest Department, Faculty of Medicine- Assiut University

  STUDY CHAIR

• Hoda A Makhlouf, MD

  Chest Department, Faculty of Medicine- Assiut University

  STUDY CHAIR

• Amany O Mohamed, MD

  Chest Department, Faculty of Medicine- Assiut University

  STUDY CHAIR

• Hamdy S Mohamed, MD

  Cardiology Department, Faculty of Medicine- Assiut University

  STUDY CHAIR

• Hatem A Helmy, MD

  Cardiology Department, Faculty of Medicine - Assiut University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 8, 2009
• First Posted: June 3, 2009
• Study Start: October 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 4, 2009
• Results First Posted: June 3, 2009

Record last verified: 2009-08

Locations

EG (1)