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

NCT ID: NCT03126838

Last Updated: 2017-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diaphragm Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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diaphragmatic dysfunction

diaphragmatic displacement \< 10 ml, and / OR diaphragmatic thickening fraction \< 36 %.

No interventions assigned to this group

non diaphragmatic dysfunction

diaphragmatic displacement \> 10 ml, and / OR diaphragmatic thickening fraction \> 36 %.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart Institute, Egypt

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ibrahim Shawky Morsy Omara

32 family housing, area 8, El obour city, Qalubia, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Heart Institute

Giza, Embaba, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Faten Fa El sayed, MD

Role: primary

00201005586659

Other Identifiers

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NHIEgypt ,670/2017

Identifier Type: -

Identifier Source: org_study_id

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