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Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome

N

National Heart Institute, Egypt

Status

Unknown

Conditions

Diaphragm Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03126838
NHIEgypt ,670/2017

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

diaphragmatic dysfunction
Description:
diaphragmatic displacement \< 10 ml, and / OR diaphragmatic thickening fraction \< 36 %.
non diaphragmatic dysfunction
Description:
diaphragmatic displacement \> 10 ml, and / OR diaphragmatic thickening fraction \> 36 %.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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