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

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

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

Study Overview

• Status: Unknown
• Conditions: Diaphragm Disease

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Embaba
    • Giza, Embaba, Egypt
      • Recruiting
      • National Heart Institute
      • Contact: Faten Fa El sayed, MD; Phone Number: 00201005586659; Email: Faten-icu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

100 adult patients who are ready for elective cardiac surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
diaphragmatic dysfunction; diaphragmatic displacement < 10 ml, and / OR diaphragmatic thickening fraction < 36 %.
non diaphragmatic dysfunction; diaphragmatic displacement > 10 ml, and / OR diaphragmatic thickening fraction > 36 %.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic excursion.	diaphragmatic excursion (displacement, cm)	at the beginning of the spontaneous breathing trial (around 4hours after surgery).
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Heart Institute, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: March 11, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: cardiac surgery; ultrasound; weaning; dysfunction; diaphragm
• Other Study ID Numbers: NHIEgypt ,670/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No