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

• Conditions: Diaphragm Disease

• Registration Number: NCT03126838
• Lead Sponsor: National Heart Institute, Egypt

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-11
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Primary Completion: 2018-03
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragmatic excursion.	at the beginning of the spontaneous breathing trial (around 4hours after surgery).	diaphragmatic excursion (displacement, cm)
diaphragmatic dysfunction post cardiac surgery.	at the beginning of the spontaneous breathing trial (around 4hours after surgery).	diaphragmatic thickening fraction \[Thickness at end inspiration - Thickness at end expiration\]; / Thickness at end expiration

Secondary Outcome Measures

Name	Time	Method
• Total ventilation time	from time of addmission to surgical ICU up to 1 week	in term of hours (in diaphragmatic dysfunction group)
• Extracorporeal circulation duration	peroperative	cardiopulmonary bypass time in term of minutes
• Diaphragm dysfunction before surgery	the day before surgery	diaphragmatic thickening fraction \[Thickness at end inspiration - Thickness at end expiration\]; / Thickness at end expiration
. Diaphragmatic excursion	the day before surgery	diaphragmatic excursion (displacement, cm)
Left ventricular ejection fraction	the day before surgery	as indicator of cardiac function
• Ventilation free days.	from time of admission to surgical ICU up to 1 week	after extubation first time tell end of ICU stay, in term of days (in diaphragmatic dysfunction group)
• Total ICU stay	from time of admission to surgical ICU up to 1 week	in term of days (in diaphragmatic dysfunction group)

Trial Locations

Locations (1)

National Heart Institute; 🇪🇬 Giza, Embaba, Egypt