Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury (CBP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Ultrasound
• Intervention / Treatment: Procedure: lung recruitment

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manil
    • Cairo, Manil, Egypt, 15699
      • Recruiting
      • Cairo University
      • Contact: maged gendy; Phone Number: 01003620361; Email: magedabdelwahab@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: recruitment group; will receive intermittent lung recruitment during CPB	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
No Intervention: control group; will recieve no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• The value of Doppler derived E/E' ratio.		Baseline,immediately at the end of operation. 2 hours after ICU admission
• 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
• Time for extubation		before extubation
Length of ICU stay		before discharge to ward up to 1 week

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ahmed agaty, professor, cairro university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Anticipated): November 20, 2018
• Study Completion (Anticipated): December 5, 2018

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 21, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: lung ultrasound after CPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No