Trial Outcomes & Findings for Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema (NCT NCT00912158)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

129 participants

Primary outcome timeframe

During ICU Stay

Results posted on

2009-09-04

Participant Flow

Location: Respiratory and Coronary Intensive Care Units of Assiut University Hospital. Patients with acute cardiogenic pulmonary oedema (CPE)

All enrolled participants were assigned to one of the three studied groups.

Participant milestones

Participant milestones
Measure	CPAP+ST Continuous positive airway pressure plus standard medical therapy	BiPAP + ST Bilevel positive airway pressure + standard medical therapy	Standard Treatment Standard medical therapy alone
Overall Study STARTED	44	44	41
Overall Study COMPLETED	44	44	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP+ST n=44 Participants Continuous positive airway pressure plus standard medical therapy	BiPAP + ST n=44 Participants Bilevel positive airway pressure + standard medical therapy	Standard Treatment n=41 Participants Standard medical therapy alone	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	12 Participants n=4 Participants	10 Participants n=27 Participants	36 Participants n=483 Participants
Age, Categorical >=65 years	30 Participants n=93 Participants	32 Participants n=4 Participants	31 Participants n=27 Participants	93 Participants n=483 Participants
Age Continuous	66 years STANDARD_DEVIATION 6.9 • n=93 Participants	68 years STANDARD_DEVIATION 3.8 • n=4 Participants	69 years STANDARD_DEVIATION 5.8 • n=27 Participants	67 years STANDARD_DEVIATION 4.8 • n=483 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	12 Participants n=4 Participants	10 Participants n=27 Participants	36 Participants n=483 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	32 Participants n=4 Participants	31 Participants n=27 Participants	93 Participants n=483 Participants
Region of Enrollment Egypt	44 participants n=93 Participants	44 participants n=4 Participants	41 participants n=27 Participants	129 participants n=483 Participants

PRIMARY outcome

Timeframe: During ICU Stay

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

Outcome measures

Outcome measures
Measure	CPAP+ST n=44 Participants Continuous positive airway pressure plus standard medical therapy	BiPAP + ST n=44 Participants Bilevel positive airway pressure + standard medical therapy	Standard Treatment n=41 Participants Standard medical therapy alone
Number of Patients Who Were Intubated	5 participants	4 participants	10 participants

SECONDARY outcome

Timeframe: Hospital stay

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maha K Ghanem, MD, FCCP

Chest Department, Faculty of Medicine, Assiut University- EGYPT

Phone: + 2 0127694434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place