Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

Lung Ultrasound Clinical Trial

— CBP  

Official title:

Bedside Lung Ultrasound to Assess Lung Recruiting Maneuver With Cardiopulmonary Bypass in Valvular Cardiac Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619525
• Other study ID #: lung ultrasound after CPB
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Ultrasound

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