Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

NCT03619525 | Unknown

• 1 other identifier: lung ultrasound after CPB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• • 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

• • Time for extubation

  before extubation

• Length of ICU stay

  before discharge to ward up to 1 week

Study Arms (2)

recruitment group

ACTIVE COMPARATOR

will receive intermittent lung recruitment during CPB

Procedure: lung recruitment

control group

NO INTERVENTION

will recieve no intervention

Interventions

lung recruitment PROCEDURE

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

recruitment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manil, 15699, Egypt

RECRUITING

Related 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. doi: 10.1016/j.ajem.2006.02.013.

  PMID: 16984837 BACKGROUND

Study Officials

• ahmed agaty, professor

  cairro university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maged el gendy, assiststant lecturer

CONTACT

2001003620361; magedabdelwahab@yahoo.com

Mohammed Hamza, lecturer

CONTACT

01006686834; mkhamza@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: numbered, sealed opaque envelope.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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 Record Dates

• First Submitted: July 25, 2018
• First Posted: August 8, 2018
• Study Start: October 20, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 5, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

EG (1)