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Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03619525
Acronym
CBP
Enrollment
60
Registered
2018-08-08
Start date
2018-10-20
Completion date
2018-12-05
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Ultrasound

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.

Interventions

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

numbered, sealed opaque envelope.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
lung ultrasound scoreBaseline,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

MeasureTime frameDescription
• 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 admissionpo2 is measured by mmhg units while PO2/fio2 is ratio
• Time for extubationbefore extubation
Length of ICU staybefore discharge to ward up to 1 week

Countries

Egypt

Contacts

Primary ContactMaged el gendy, assiststant lecturer
magedabdelwahab@yahoo.com2001003620361
Backup ContactMohammed Hamza, lecturer
mkhamza@kasralainy.edu.eg01006686834

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026