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

NCT06513702 | Not Yet Recruiting

• 1 other identifier: RSCH ID-24-03856-CTF
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of lung atelectasis intraoperatively after TELUS guided recruitment

  assessed by TOE during sternal wiring after recruitment maneuver

  intraoperatively

Secondary Outcomes (1)

• Severity of Postoperative pulmonary complications.

  30 days

Study Arms (2)

Recruitment maneuver group

EXPERIMENTAL

Participant received TELUS guided lung reinflation during CPB weaning and TELUS guided recruitment maneuver during sternal wiring

Procedure: Transesophageal lung ultrasound (TELUS) guided recruitment maneuver

Control group

ACTIVE COMPARATOR

Participant received manual bag lung inflation during CPB weaning

Other: Manual bag lung reinflation

Interventions

Transesophageal lung ultrasound (TELUS) guided recruitment maneuver PROCEDURE

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

Recruitment maneuver group

Manual bag lung reinflation OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• European System for Cardiac Operative Risk Evaluation (Euroscore) 1-6

You may not qualify if:

• 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
• BMI \<20, \> 35
• Patient needed for re-do surgery.
• Patient on ventricular assist device.

Sponsors & Collaborators

• University of Malaya: lead

Study Officials

• Mohd Fitry bin Zainal Abidin

  Consultant Anaesthesiologist Universiti Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Fitry bin Zainal Abidin

CONTACT

+60379492052; mohdfitry@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center,prospective, a randomized controlled trial (RCT) study in cardiac surgery patient.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after 1 year
• Access Criteria: through email