To Determine the Effectiveness of Transesophageal Lung Ultrasound Guided Recruitment Maneuver in Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Malaya

About this trial

This study is to evaluate the effectiveness of Transesophageal Lung ULtrasound (TELUS) guided recruitment maneuver to reduce lung atelelectasis in cardiac surgery. This is a RCT trial involving a cardiac patient that requiring used of cardiopulmonary bypass machine intraoperatively. These patient will be randomized into either intervention group or control group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 to 70 years old.

Elective cardiac surgery that requires used of transoesophageal ECHO.

New York Heart Association class I or II or III

Preoperative LV ejection fraction >40%

Disqualifiers

Pregnancy

Contraindication to transoesophageal ECHO - oesophageal tumour, stricture, diverticulum, or recent oesophageal or gastric surgery

Previous lung surgery/ history of lung radiation for cancer

Severe obstructive/ restrictive lung disease- Examples: Patient with home CPAP, frequent hospitalization and ICU admissions due to lung disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transesophageal lung ultrasound (TELUS) guided recruitment maneuver

    Procedure/Surgery

    1. Lung reinflation guided by transesophageal lung ultrasound (TELUS) after cardiopulmonary bypass weaning 2. TELUS guided recruitment maneuver with continuous positive pressure of 30cmh20 for 20 seconds and 40cmh20 for 20 seconds during sternal wiring

  • Manual bag lung reinflation

    Other intervention

    After weaning of CPB, Lung will be reinflated by 5 deep manual bag infaltion until full inflation observed by the anesthetist. During sternal wiring, Lung ultrasound will be examine - LUNG ultrasound score will be taken- no recruitment maneuver will be done in this contro group (Basically this group of patient is a routine practice in cardiac surgery

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Recruitment maneuver groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of lung atelectasis intraoperatively after TELUS guided recruitment

assessed by TOE during sternal wiring after recruitment maneuver

Time frame
intraoperatively

Secondary outcomes

1

Severity of Postoperative pulmonary complications.

Grade 0 - Absence of any complications Grade 1 - Cough, dry * Microatelectasis: abnormal lung findings and temperature \> 37.5°C without other documented cause; normal CXR Grade 2 - Cough, productive * Bronchospasm * Hypoxemia (SpO2 ≤ 90%) at room air * Atelectasis: gross radiological confirmation plus either temperature \> 37.5°C or abnormal lung findings * Hypercarbia (PaCO2 \> 50 mmHg), requiring treatment Grade 3 - Pleural effusion, resulting in thoracentesis * Pneumonia- requiring change of antibiotic * Pneumothorax * Noninvasive ventilation- Re-intubation , with period of ventilator dependence (non-invasive or invasive ventilation) ≤ 48 hours Garde 4 - Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with ventilator dependence exceeding 48 hours Grade 5 Death before hospital discharge

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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