| CTRI Number |
CTRI/2024/05/066897 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A pilot study comparing two airway protection devices to provide general anesthesia during hepatobiliary surgery. |
|
Scientific Title of Study
|
LMA Proseal a safe alternative to Endotracheal intubation for prolonged hepatobiliary surgery: a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak K Tempe |
| Designation |
MBBS,MD,FRCA, FAMS, Professor &Head of Department of Anesthesiology |
| Affiliation |
Institute of Liver & Biliary Sciences |
| Address |
Department of Anesthesiology,
3rd floor Phase 2
ILBS hospital
New Delhi
South
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
tempedeepak@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniruddha Banerjee |
| Designation |
DM student |
| Affiliation |
Institute of Liver & Biliary Sciences |
| Address |
ILBS, department of Anesthesia.
Vasant kunj,D1
New Delhi
South
DELHI
110070
India |
| Phone |
8583807964 |
| Fax |
|
| Email |
banerjeeaniruddha194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniruddha Banerjee |
| Designation |
DM student |
| Affiliation |
Institute of Liver & Biliary Sciences |
| Address |
ILBS, department of Anesthesia,
Vasant kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
8583807964 |
| Fax |
|
| Email |
banerjeeaniruddha194@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences, Vasant kunj D1, New Delhi,11070, India |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Vasant Kunj,D1, New Delhi
110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aniruddha Banerjee |
Institute of Liver and Biliary Sciences |
ILBS, Department of Anesthesia, vasant kunj, New Delhi
New Delhi
DELHI |
08583807964
banerjeeaniruddha194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Institute of Liver & Biliary Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal tube |
In group B endotracheal tube will be placed after induction after direct vision laryngoscopy. In male 8.0 or 8.5 mm ID or in case of female 7.0 or 7.5mm ID PVC cuffed Endo-tracheal tube will be inserted. Bilateral air entry will be checked. |
| Intervention |
LMA Proseal |
Patients will be allotted after written informed consent is given by them and they will be allotted in two groups: group A & group B according to sequential randomization method. Their age, sex, diagnosis, comorbidity, ASA classification will be collected prior surgery. Patients will be blinded to the group they are allotted.
All patients will be kept nil per oral for at least 8 hours for solid food and 2 hours for clear liquid. They will be prescribed tablet alprazolam 0.25mg on the night prior to surgery as premedication.
Prior to induction standard monitoring device will be attached to all the patients and baseline vitals will be recorded. Patients will be preoxygenated with 100% FiO2 to achieve end tidal oxygen of more than 90%. Patients will be induced with propofol (1-2mg/kg), fentanyl (2-3mcg/kg) and rocuronium (1-1.2mg/kg). Post induction arterial line will be placed for invasive blood pressure recording.
In patients allotted in group A, Proseal LMA will be inserted with the help of introducer. Size of LMA will be decided according to patient’s weight and manufacture’s specification. After insertion of Proseal LMA the seal pressure will be gradually increased till an effective seal is achieved and the pressure will be recorded. The seal pressure will be monitored throughout surgery with the help of cuff pressure manometer. Position of the LMA will be confirmed by fiberoptic bronchoscope. Bilateral air entry will be checked. After completion of surgery LMA will be removed after adequate reversal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of ASA grade I, II, III undergoing hepatobiliary surgery in Institute of liver and biliary science where expected duration of surgery is ≥ 6 hours and gut handling during surgery is minimal |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway
Inadequate NPO status
Obese, BMI more than 35
ASA grade IV, V with serious comorbidities.
Emergency surgeries
Patient who has not given consent to participate in study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective is to assess feasibility of LMA Proseal by means of ventilatory efficacy and pulmonary gas exchange in prolonged hepatobiliary surgery and to compare its efficacy with endotracheal tube.
Ventilatory efficacy will be evaluated by means of peak pressure, driving pressure, leak (discrepancy between inspiratory and expiratory tidal volume).
Pulmonary gas exchange will be evaluated as PaO2, PaCO2, ETCO2.
|
base line, hourly parameter at 1st,2nd,3rd,4th,5th,6th, 7th,8th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variation during insertion and emergence |
baseline, 0,1,3,5,10 minutes after insertion of LMA or ET tube, after discontinuation of anesthesia,time of extubation, 5 minutes post extubation |
| incidence of post operative nausea vomiting, postoperative pulmonary complications, hoarseness of voice, sore throat |
up to 3 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/05/2024 |
| 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="1"
Months="1"
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
|
General anesthesia
is considered essential for upper abdominal surgery and endotracheal intubation
is conventionally used for it. Since the
introduction of laryngeal mask airway (LMA) in 1980s (1) it has
replaced endotracheal intubation in many circumstances for maintenance of
airway in patients under general anesthesia.
LMA provides several advantages over ET tube by means of ease of
insertion, reduced post-operative sore throat, dysphagia, tracheal trauma,
vocal cord injury, improved hemodynamic stability during insertion and
emergence from anesthesia(2) .
However, there is concern regarding LMA not being a definitive airway.
Theoretically there is possibility of inadequate ventilation, improper seal and
most importantly pulmonary aspiration(3,4) .So, prolonged surgery,
laparoscopic surgery are conventionally regarded as a relative contraindication
for LMA use(5) .
However second
generation LMA like Proseal LMA, provide better seal and with its gastric
drainage channel provide improved safety for aspiration(6).
Therefore, nowadays LMA has been used for even prolonged duration of surgery
and some author have used it safely in surgeries lasting for as long as 5 to 11
hours (7).-
Although the safety and
efficacy of second generation airway has been proven but for more prolonged use
where surgery may last for more than six
hours conventionally endotracheal intubation is used and data regarding such prolonged use of LMA is also limited. So a pilot study is to be conducted to assess the
efficacy of Proseal LMA in patient undergoing prolonged hepatobiliary surgery and compare it with patients in whom endotracheal tube is used for general
anesthesia.
Based on the results further RCTs can be performed
in patients undergoing prolonged
abdominal surgery.
References: 1.
Brain, A. I. Te laryngeal mask—A new concept in airway management. Br. J.
Anaesth. 55, 801–805.(1983). 2.
Timmermann, A., Bergner, U. A. & Russo, S. G. Laryngeal mask airway
indications: New frontiers for second-generation supraglottic airways. Curr.
Opin. Anaesthesiol. 28, 717–726 (2015). 3.
Asai, T. Complications with supraglottic airways: something to worry about or
much ado about nothing?. Anesthesiology 116,
1183–1185
(2012). 4.
Ramachandran, S. K., Mathis, M. R., Tremper, K. K., Shanks, A. M. &
Kheterpal, S. Predictors and clinical outcomes from failed
laryngeal
mask airway unique: A study of 15,795 patients. Anesthesiology 116, 1217–1226
(2012).
5.
van Esch, B. F., Stegeman, I. & Smit, A. L. Comparison of laryngeal mask
airway vs tracheal intubation: A systematic review on airway complications. J.
Clin. Anesth. 36, 142–150. (2017).
6. Moser B, Audigé L, Keller C, Brimacombe J,
Gasteiger L, BruppacherHR. A prospective, randomized trial of the Ambu
AuraGainTM laryngealmask versus the LMA® protector airway in paralyzed,
anesthetized adult men. Minerva Anestesiol 2018;84:684–92.
7.
Moser B, Brimacombe J, Sharma B, Dutta A, Sood J, et al. (2017) Prolonged Use
of the Laryngeal Mask Airway ProSealTM: A Report of Seven Cases Lasting 5-11 h.
J Anesth Clin Res 8: 717. doi:10.4172/2155-6148.1000717 |