Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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10 October 2016 |
Main ID: |
NCT02262182 |
Date of registration:
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07/10/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAPĀ® After Cardiac Surgery in the Management of Postoperative Atelectasis
PEPKIN |
Scientific title:
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Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAPĀ® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery |
Date of first enrolment:
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November 2014 |
Target sample size:
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80 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02262182 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients admitted in ICU after cardiac surgery by sternotomy with cardiopulmonary
bypass presenting a pulmonary atelectasis after extubation, diagnosed by chest X-ray
in postoperative period (day1 to day 2).
- Patients over 18 years of age
- Informed patient
Exclusion Criteria:
- Cardiac arrhythmia
- Hemodynamic instability (mean blood pressure < 65 mmHg or > 95 mmHg)
- Respiratory rate > 35/min
- Undrained pneumothorax
- Predictable trachea intubation or emergent surgery
- Patient oral refusal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Atelectasis
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Intervention(s)
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Other: KP group
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Other: KM group
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Primary Outcome(s)
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Radiological atelectasis score
[Time Frame: Day 2 post-inclusion]
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Secondary Outcome(s)
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Inspiratory pressure measurement
[Time Frame: Days 2 and 3 post inclusion]
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Assessment of patient satisfaction and tolerance of EzPAP device
[Time Frame: Day 3 post inclusion]
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Vesicular murmur intensity
[Time Frame: Days 1, 2 and 3 post inclusion]
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Pain evaluation
[Time Frame: Days 1, 2 and 3 post inclusion]
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Cardiac and respiratory rate
[Time Frame: Days 1, 2 and 3 post inclusion]
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Dyspnea evaluation
[Time Frame: Days 1, 2 and 3 post inclusion]
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Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session
[Time Frame: Days 1, 2 and 3 post inclusion]
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Radiological atelectasis score
[Time Frame: Days 1 and 3 post-inclusion]
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SpO2/FiO2 ratio
[Time Frame: Days 1, 2 and 3 post inclusion]
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Secondary ID(s)
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RC14_0033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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