Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

NCT ID: NCT03619525

Last Updated: 2018-10-23

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-20

Study Completion Date

2018-12-05

Brief Summary

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The study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water.

Detailed Description

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Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with CPB. The investigators will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW).

Objectives :

To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on:

Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay

sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.

Conditions

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Lung Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
numbered, sealed opaque envelope.

Study Groups

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recruitment group

will receive intermittent lung recruitment during CPB

Group Type ACTIVE_COMPARATOR

lung recruitment

Intervention Type PROCEDURE

During bypass, patients in this group will receive a lung protective design in the form of continuous positive airway pressure (CPAP) by closing APL valve at pressure of 5 Cm H2o combined with intermittent recruitment by sustained manual lung inflation at a pressure of 35 cmH2O for 30 seconds every (30-40) minute

control group

will recieve no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lung recruitment

During bypass, patients in this group will receive a lung protective design in the form of continuous positive airway pressure (CPAP) by closing APL valve at pressure of 5 Cm H2o combined with intermittent recruitment by sustained manual lung inflation at a pressure of 35 cmH2O for 30 seconds every (30-40) minute

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged (18-60 years),
* elective valvular cardiac surgery with cardiopulmonary bypass (CPB).

Exclusion Criteria

* • Emergency surgeries.

* coronary artery bypass graft surgery
* patients requiring re-exploration in the immediate postoperative period (within 2hours)
* left Ventricular ejection fraction less than 40%
* patients with preoperative congestive heart failure, cardiogenic shock , preoperative pulmonary edema
* pre-existing severe chronic pulmonary dysfunction (defined as pulmonary disease requiring home oxygen therapy or causing shortness of breath after 1 to 2 flights of stairs)
* Morbid obesity
* Renally impaired patients with creatinine more than 2 mg/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Maged Abdel-Wahab Abdel-Aziz

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed agaty, professor

Role: PRINCIPAL_INVESTIGATOR

cairro university

Locations

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Cairo University

Cairo, Manil, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maged el gendy, assiststant lecturer

Role: CONTACT

2001003620361

Mohammed Hamza, lecturer

Role: CONTACT

01006686834

Facility Contacts

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maged gendy

Role: primary

01003620361

References

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Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

Reference Type BACKGROUND
PMID: 16984837 (View on PubMed)

Other Identifiers

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lung ultrasound after CPB

Identifier Type: -

Identifier Source: org_study_id

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