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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03126838
Other study ID # NHIEgypt ,670/2017
Secondary ID
Status Recruiting
Phase N/A
First received March 11, 2017
Last updated April 21, 2017
Start date March 1, 2017
Est. completion date September 2018

Study information

Verified date April 2017
Source National Heart Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt National Heart Institute Giza Embaba

Sponsors (1)

Lead Sponsor Collaborator
National Heart Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

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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