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

Diaphragm Disease Clinical Trial

Official title:

Diaphragmatic Dysfunction and Cardiac Surgery; Perioperative Assessment and Effect on Outcome; Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03126838
• Other study ID #: NHIEgypt ,670/2017
• 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
• 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.

Related Conditions & MeSH terms

• Diaphragm Disease

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