Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

Not Applicable

• Conditions: Lung Ultrasound
• Interventions: Procedure: lung recruitment

• Registration Number: NCT03619525
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Status Verified: 2018-10
• Study Start: 2018-10-20
• Last Update Submitted: 2018-10-21
• Last Update Posted: 2018-10-23
• Primary Completion: 2018-11-20
• Study Completion: 2018-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recruitment group	lung recruitment	will receive intermittent lung recruitment during CPB

Primary Outcome Measures

Name	Time	Method
lung ultrasound score	Baseline,immediately at the end of operation. 2 hours after ICU admission	• 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

Secondary Outcome Measures

Name	Time	Method
• The value of Doppler derived E/E' ratio.	Baseline,immediately at the end of operation. 2 hours after ICU admission
• Oxygenation (po2),& (po2/fio2)	Baseline,immediately at the end of operation. 2 hours after ICU admission	po2 is measured by mmhg units while PO2/fio2 is ratio
• Time for extubation	before extubation
Length of ICU stay	before discharge to ward up to 1 week

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Manil, Egypt