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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03619525
Other study ID # lung ultrasound after CPB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2018
Est. completion date December 5, 2018

Study information

Verified date October 2018
Source Cairo University
Contact Maged el gendy, assiststant lecturer
Phone 2001003620361
Email magedabdelwahab@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 5, 2018
Est. primary completion date November 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Cairo University Cairo Manil

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary lung ultrasound score • The change of lung ultrasound score (a score ranging fom 0/36 to 36/36 where 0/36 is best while 36/36 is worst) from the baseline values for assessment of extra vascular lung water after CBP Baseline,immediately at the end of operation. 2 hours after ICU admission
Secondary • The value of Doppler derived E/E' ratio. Baseline,immediately at the end of operation. 2 hours after ICU admission
Secondary • Oxygenation (po2),& (po2/fio2) po2 is measured by mmhg units while PO2/fio2 is ratio Baseline,immediately at the end of operation. 2 hours after ICU admission
Secondary • Time for extubation before extubation
Secondary Length of ICU stay before discharge to ward up to 1 week
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