Clinical trial NCT03126838: Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome
Official title: Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome; Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diaphragm Disease
Keywords: diaphragm
ultrasound
dysfunction
cardiac surgery
weaning
Lead sponsor: National Heart Institute, Egypt
Sponsor class: OTHER_GOV
First posted: 2017-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 adult patients who are ready for elective cardiac surgery.

Brief summary: This study evaluates incidence of diaphragmatic dysfunction after cardiac surgery and its effect on outcome of surgery.

Detailed description: Diaphragmatic dysfunction will be assessed by ultrasonography the day before operation and first post operative day, by measuring diaphragmatic thickening during inspiration and expiration.incidence of diaphragmatic dysfunction and its effect on outcome of surgery then will be analysed.

Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragmatic excursion.
timeFrame: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
measure: diaphragmatic dysfunction post cardiac surgery.
timeFrame: at the beginning of the spontaneous breathing trial (around 4hours after surgery).
Secondary outcomes:
measure: . Diaphragmatic excursion
timeFrame: the day before surgery
measure: • Diaphragm dysfunction before surgery
timeFrame: the day before surgery
measure: Left ventricular ejection fraction
timeFrame: the day before surgery
measure: • Total ventilation time
timeFrame: from time of addmission to surgical ICU up to 1 week
measure: • Extracorporeal circulation duration
timeFrame: peroperative
measure: • Ventilation free days.
timeFrame: from time of admission to surgical ICU up to 1 week
measure: • Total ICU stay
timeFrame: from time of admission to surgical ICU up to 1 week
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Heart Institute
state: Embaba
Study officials:
References: