| CTRI Number |
CTRI/2024/06/068482 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Transesophageal echo insertion on endotracheal tube cuff pressure in adult patients |
|
Scientific Title of Study
|
Effect of transoesophageal echocardiography probe insertion on endotracheal tube cuff pressure in adult CABG surgeries
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akireeti |
| Designation |
MD Anaesthesia,senior resident |
| Affiliation |
ESIC superspeciality hospital |
| Address |
ESIC superspeciality hospital,department of anaesthesia,1st floor,room number 1002,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9160729260 |
| Fax |
|
| Email |
kireeti55chinna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravikanth pula |
| Designation |
MD Anaesthesia,specialist |
| Affiliation |
ESIC superspeciality hospital |
| Address |
ESIC superspeciality hospital,department of anaesthesia,1st floor,room number 1002,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9666977781 |
| Fax |
|
| Email |
ravi.kanthpula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravikanth pula |
| Designation |
MD Anaesthesia,specialist |
| Affiliation |
ESIC superspeciality hospital |
| Address |
ESIC superspeciality hospital,department of anaesthesia,1st floor,room number 1002,sanath nagar,hyderabad,telangana-500038
TELANGANA
500038
India |
| Phone |
9666977781 |
| Fax |
|
| Email |
ravi.kanthpula@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC superspeciality hospital,sanath nagar,hyderabad |
|
|
Primary Sponsor
|
| Name |
ESIC superspeciality hospital |
| Address |
ESIC superspeciality hospital,sanath nagar,hyderabad,telangana-500038 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravikanth |
ESIC superspeciality hospital |
ESIC superspeciality hospital,department of anaesthesia,1st floor,room number 1002,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA |
9666977781
ravi.kanthpula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Esic medical college and hospital and Esic super speciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cuff pressure monitoring |
After the patient is brought to the operation theatre,standard monitoring such as electrocardiography and pulse oximetry were applied. Invasive blood pressure monitoring line and central venous catheter through right internal jugular vein will be inserted under standard aseptic precautions. Induction of anesthesia will be done with midazolam0.08-0.1mg/kg, fentanyl 5-10mcg/kg, and etomidate 0.2-0.4mg/kg. In all cases rocuronium 0.6-1.2mg/kg will be used as muscle relaxant. After induction of anesthesia, appropriate sized (7 for female and 8 for male) cuffed high volume low pressure endotracheal tube (ETT-portex) will be used to secure the airway. The proper placement of the ETT will be confirmed with appearance of end tidal carbon dioxide (EtCO2) tracing and auscultation over chest for bilateral air entry. The cuff of the ETT will be slowly inflated/deflated using the air leak technique by putting the stethoscope on the suprasternal notch with slow inflation of the cuff until there will be no audible air leak while holding continuous positive airway pressure (CPAP) of 20 cmH2O with the head and neck in the neutral position to seal the airway. Mechanical ventilation will be started with volume‑controlled mode with the tidal volume of 8ml/kg, respiratory rate of 12 per minute, inspiratory/expiratory ratio of 1:2 and fraction of inspired oxygen (FiO2) 0.5 with an air‑oxygen mixture with sevoflurane. Positive end‑expiratory pressure will not be applied. After the ETT cuff is inflated with 7ml of air, the baseline cuff pressure will be measured using a manometer(AMBU MANOMETER) and recorded. An Experienced cardiac anesthesiologist will insert the TEE probe(MIND RAY,8mm) after adequate lubrication with brief jaw thrust maneuver. Bite guard will be applied before TEE probe placement. If there is failure in blind insertion of TEE probe after two attempts, the probe will be inserted using direct laryngoscopy, or the procedure will be abandoned if significant resistance is encountered and these patients will be excluded from the study. TEE associated complications (e.g., dental injury, upper gastrointestinal bleeding, and esophageal/gastric injury) will be noted.
The cuff pressures will be recorded at three points of time; before the insertion of the TEE as a baseline (T1); during TEE probe manipulation(T2) and immediately after completion of initial TEE examination (T3).If the pressure is found to be persistently 30 cm of H2O at T2 & T3, it will be adjusted back to 20–30 cm of H2O. If there is an audible air leak or inadequate ventilation because of loss of tracheal seal,tracheal cuff will be reinflated with air to maintain adequate seal.
|
| Comparator Agent |
cuff pressure monitoring without adjustment |
The cuff pressures will be recorded at three points of time; before the insertion of the TEE as a baseline (T1); during TEE probe manipulation(T2) and immediately after completion of initial TEE examination (T3).Cuff pressures will be monitored without any adjusting.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who provided informed consent for participation in the study
2.Patients belonging to American Society of Anaesthesiologists physical status between I and III, aged between 18-70 years of either gender, undergoing Cardiac surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1.Difficult airway
2.Emergency surgeries
3. Extremes of ages
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreased intraoperative intra cuff pressure leading to decrease posr operative airway complications.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of TEE probe manipulation on cuff pressure |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PURPOSE :A decrease in intraoperative intracuff pressure during TEE probe manupulation leading to decrease in post operative airway complications in adults patients undergoing CABG surgery.
DESIGN: A Prospective, interventional study
PARTICIPANT :patients undergoing elective CABG surgeries with endotracheal intubation under general anesthesia
INTERVENTION:Patients
will be randomised into two groups,
control C group (25
members) and Test T
group (25 members).In both the groups C and T, the cuff pressures will be
recorded at 4 points of time;before insertion of the TEE
as a baseline (T1),immediately after insertion (T2),during TEE probe
manipulation(T3) and immediately after completion of initial TEE examination
(T4).In group C, cuff pressures will be
monitored without any intervention and in
group T if the pressure is found to be persistently >30 cm of H2O, it
will be adjusted back to 20–30 cm of H2O.
MAIN OUTCOME MEASURES:This
study can be useful to optimize the endotracheal cuff pressure value after TEE probe
insertion in order to avoid the unwanted adverse effects |