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

Sponsor

National Heart Institute, Egypt (Other)

Overall Status

Unknown status

CT.gov ID

NCT03126838

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 %.

Outcome Measures

Primary Outcome Measures

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

. Diaphragmatic excursion [the day before surgery]
diaphragmatic excursion (displacement, cm)
• Diaphragm dysfunction before surgery [the day before surgery]
diaphragmatic thickening fraction [Thickness at end inspiration - Thickness at end expiration] / Thickness at end expiration
Left ventricular ejection fraction [the day before surgery]
as indicator of cardiac function
• 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
• 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Heart Institute	Giza	Embaba	Egypt

Sponsors and Collaborators

National Heart Institute, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ibrahim Shawky Morsy Omara, 32 family housing, area 8, El obour city, Qalubia, Egypt, National Heart Institute, Egypt

ClinicalTrials.gov Identifier:

NCT03126838

Other Study ID Numbers:

NHIEgypt ,670/2017

First Posted:

Apr 24, 2017

Last Update Posted:

Apr 24, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ibrahim Shawky Morsy Omara, 32 family housing, area 8, El obour city, Qalubia, Egypt, National Heart Institute, Egypt

Study Results

No Results Posted as of Apr 24, 2017