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Coronary Artery Bypass SurgeryTELUS-REMNCT06513702

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

A study testing Transesophageal lung ultrasound (TELUS) guided recruitment maneuver and Manual bag lung reinflation in people with Coronary Artery Bypass Surgery, run by University of Malaya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Coronary Artery Bypass Surgery
What is being tested?
Transesophageal lung ultrasound (TELUS) guided recruitment maneuver and Manual bag lung reinflation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Aug 2024to Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Mohd Fitry bin Zainal Abidin contact

+60379492052

mohdfitry@um.edu.my

About this study

Official title: The Effectiveness of Transesophageal Lung Ultrasound (TELUS) Guided Recruitment Maneuver to Reduce Lung Atelectasis After Cardiac Surgery: a Randomized Controlled 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.

Read the detailed description

Post operative pulmonary complications is a common cause of morbidity and mortality in cardiac surgery. Lung atelectasis (collapse) contributes to dysfunctional of right ventricular performance post cardiac surgery, due to increase impedance in right ventricular outflow tract. Recruitment (Lung re-expansion) maneuver is proven to be effective to reverse this effect, however it is not routinely done intraoperatively. In this study , we are conducting a randomized controlled trial to evaluate effectiveness of transesophageal lung ultrasound (TELUS) guided recruitment maneuver to reduce incidence of lung atelectasis in cardiac surgery. By this intervention, we hope that it will lead to reduce the incidence of postoperative pulmonary complications after undergoing cardiopulmonary bypass surgery.

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

Patient will be randomized into 2 groups after consented into this study. After the operating list has been confirmed, we will visit the patients to be recruited, explain the purposes of this study, and then offer them to participate in this study. If the patients agree to participate in this study, they will need to sign a consent form in Malay or English language. Each participant will be assigned a code number to protect their confidentiality and the code number will be written clearly on an opaque envelope. The opaque envelope will contain participant's consent form, patient information sheet, and data collection sheet. Patient will be randomized by computer generated system into control group (group C) and recruitment maneuver group (group RM).

On the day of operation, the operation will be proceeded under general anesthesia as per standard practice. Induction and maintenance of anesthesia will be conducted as per standard practice.

Standard arterial and central venous catheterization will be inserted in all patients. The operation will be proceeded as per usual practice. The patient will be put on cardiopulmonary bypass (CBP) machine as per usual practice and the operation will be done as per scheduled. Mechanical ventilator will be suspended during CBP. Once CBP was disconnected, lung will be reinflated by giving five deep manual bag insufflations until full lung expansion observed by anaesthetist, however in interventional group lung inflation is guided by transesophageal lung ultrasound. During sternal wiring approximately about 30 minutes before the end of surgery, in interventional group they will receive a lung recruitment maneuver by continuous CPAP at 30cmH2o for 20seconds followed by PEEP 0f 8cmH20. In both groups, lung ultrasound and heart ultrasound (TOE) will be done to evaluate lung and heart function. Further assessment will be done in RM group with lung and heart ultrasound to look for changes after lung recruitment maneuver. If there is still evidence of lung collapse in the second assessment, repeated lung recruitment maneuver will be done with continuous CPAP at 40cmh20 for 20 seconds. The lung recruitment maneuver will be immediately stopped if there were signs of hypovolaemia, impairment in right ventricular contraction or a change at least 15% of baseline MAP and HR or desaturation.

Once operation is completed, patients will be reassessed again by heart ultrasound. The patient then will be transferred to the Cardiac Intensive Care Unit (CICU). The patient will be wean off from mechanical ventilator once condition permitted.

After surgery, the investigator will assess patients daily to obtain the clinical data. The patient then will be continued to be follow up until the day of discharge from hospital.

Being tested
Transesophageal lung ultrasound (TELUS) guided recruitment maneuver, Manual bag lung reinflation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transesophageal lung ultrasound (TELUS) guided recruitment maneuverProcedure or 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 reinflationOther

    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

Study groups in NCT06513702
Study groupRoleWhat they receive
Recruitment maneuver groupExperimentalParticipant received TELUS guided lung reinflation during CPB weaning and TELUS guided recruitment maneuver during sternal wiring
Receives: Procedure: Transesophageal lung ultrasound (TELUS) guided recruitment maneuver
Control groupActive comparatorParticipant received manual bag lung inflation during CPB weaning
Receives: Other: Manual bag lung reinflation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of lung atelectasis intraoperatively after TELUS guided recruitment

    assessed by TOE during sternal wiring after recruitment maneuver

    Measured: intraoperatively

Secondary outcomes (1)
  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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a single center,prospective, a randomized controlled trial (RCT) study in cardiac surgery patient.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06513702
Sponsor's protocol ID
RSCH ID-24-03856-CTF
Acronym
TELUS-REM
Status last verified
Jul 2024
First submitted
16 Jul 2024
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: By request

Questions about this trial

What is this clinical trial studying?

A study testing Transesophageal lung ultrasound (TELUS) guided recruitment maneuver and Manual bag lung reinflation in people with Coronary Artery Bypass Surgery, run by University of Malaya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohd Fitry bin Zainal Abidin (+60379492052, mohdfitry@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of lung atelectasis intraoperatively after TELUS guided recruitment (time frame: intraoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.

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