Diaphragm Disease Clinical Trial
Official title:
Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome; Prospective Observational Study
Verified date | April 2017 |
Source | National Heart Institute, Egypt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years old and older - Planned cardiac surgery - Ready for weaning from mechanical ventilation (fraction of inspired oxygen (FIO2) = 50%, positive end-expiratory pressure(PEEP) level= 5 centimeter water (cmH2O), respiratory rate =30 breaths/min, partial pressure of oxygen in arterial blood(PaO2)/FIO2 ratio >200 , Glasgow coma score =14). - Stable cardiovascular status (i.e., heart rate <120 beats/min; systolic blood pressure, 90-160 mmHg; and no or minimal vasopressor use, i.e., dopamine or dobutamine =5 µg/kg/min or noradrenaline =0.05 µg/kg/min). - Stable metabolic status (i.e., electrolytes and glycaemia within normal range, body temperature <38 °C, hemoglobinemia =8-10 g/dL). Exclusion Criteria: - Patients with a history of diaphragmatic or neuromuscular disease or evidence of pneumothorax or pneumomediastinum. - Patients with low EF (EF = 30%). - Patients with post-operative cerebrovascular stroke. - Reventilation due to cardiac cause ( arrest, arrhythmias, or failure) - Patient refusal. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Heart Institute | Giza | Embaba |
Lead Sponsor | Collaborator |
---|---|
National Heart Institute, Egypt |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragmatic excursion. | diaphragmatic excursion (displacement, cm) | at the beginning of the spontaneous breathing trial (around 4hours after surgery). | |
Primary | diaphragmatic dysfunction post cardiac surgery. | diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration] / Thickness at end expiration |
at the beginning of the spontaneous breathing trial (around 4hours after surgery). | |
Secondary | . Diaphragmatic excursion | diaphragmatic excursion (displacement, cm) | the day before surgery | |
Secondary | • Diaphragm dysfunction before surgery | diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration] / Thickness at end expiration |
the day before surgery | |
Secondary | Left ventricular ejection fraction | as indicator of cardiac function | the day before surgery | |
Secondary | • Total ventilation time | in term of hours (in diaphragmatic dysfunction group) | from time of addmission to surgical ICU up to 1 week | |
Secondary | • Extracorporeal circulation duration | cardiopulmonary bypass time in term of minutes | peroperative | |
Secondary | • Ventilation free days. | after extubation first time tell end of ICU stay, in term of days (in diaphragmatic dysfunction group) | from time of admission to surgical ICU up to 1 week | |
Secondary | • Total ICU stay | in term of days (in diaphragmatic dysfunction group) | from time of admission to surgical ICU up to 1 week |
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