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

NCT03126838 | Unknown

• 1 other identifier: NHIEgypt ,670/2017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diaphragm Disease

Keywords

diaphragm; ultrasound; dysfunction; cardiac surgery; weaning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• . Diaphragmatic excursion

  the day before surgery

• • Diaphragm dysfunction before surgery

  the day before surgery

• Left ventricular ejection fraction

  the day before surgery

• • Total ventilation time

  from time of addmission to surgical ICU up to 1 week

• • Extracorporeal circulation duration

  peroperative

Study Arms (2)

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 %.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 adult patients who are ready for elective cardiac surgery.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart Institute, Egypt: lead

Study Sites (1)

National Heart Institute

Giza, Embaba, Egypt

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 32 family housing, area 8, El obour city, Qalubia, Egypt

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: April 24, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)