| CTRI Number |
CTRI/2022/04/042302 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
03/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate if LMA Gastro can be used as a safe alternative to endotracheal tube in General Anesthesia for successfully completing Endoscopic procedures.
|
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Scientific Title of Study
|
Efficacy of the new LMA Gastro Airway as an Airway device in patients undergoing Endoscopic procedures under General Anaesthesia: a single centre observational study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Babykutty |
| Designation |
Post Graduate resident |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
07837649718 |
| Fax |
|
| Email |
rashmibabykutty11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rashmi Babykutty |
| Designation |
Post Graduate resident |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
07837649718 |
| Fax |
|
| Email |
rashmibabykutty11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rashmi Babykutty |
| Designation |
Post Graduate resident |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
07837649718 |
| Fax |
|
| Email |
rashmibabykutty11@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHRISTIAN MEDICAL COLLEGE, VELLORE |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE VELLORE |
| Address |
CHRISTIAN MEDICAL COLLEGE, VELLORE TAMIL NADU632004 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRaj Sahajanandan |
CHRISTIAN MEDICAL COLLEGE VELLORE |
Gastroscopy and ERCP Suite,CHRISTIAN MEDICAL COLLEGE VELLORE TAMIL NADU Vellore TAMIL NADU |
8489622336
rajsahajanandan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD CMC VELLORE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil Intervention |
Nil Intervention |
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All American Society of Anesthesiologists (ASA) 1and 2 patients who will require Upper GI Endoscopic procedure under General Anesthesia and have consented to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who refuse to consent
2. ASA 3 and above
3. Anticipated difficult airway
4. High risk of aspiration
5. Cardiac diseases
6. Airway anomalies
7. Emergency endoscopic procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to look at the percentage of Successful placement of LMA Gastro, which is defined as, Tidal volumes more than or equal to 4ml per kg, No peak pressures more than 30 cm of H2O and a good EtCo2 waveform in the range of 28 to 30 |
Intraoperative period ,approximately 30mins to 1 hour |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hemodynamic Instability |
Intraoperative period, approximately 30mins to 1 hour |
| Incidence of airway compromise |
Intraoperative period, approximately 30mins to 1 hour |
| Incidence of laryngospasm |
Intraoperative period, approximately 30mins to 1 hour |
| Incidence of post procedural Sore throat |
30mins after completion of procedure |
|
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Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2022 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Laryngeal mask airway, a supraglottic airway device, over the years has gained popularity in various settings like, management of difficult airway, cardiopulmonary resuscitation and non operating room anesthesia. With the advancement of interventional endoscopic procedures, the gastroenterology suite is a growing area for non operating room anesthesia as the practice is inclining more towards deep sedation / general anesthesia rather than conscious sedation. Though general anesthesia is the choice in practice, the need for a safer, fast and gentle airway device is necessary. LMA Gastro is a new 2nd generation supraglottic airway device which is specially designed for Upper Gastrointestinal endoscopy. It comes with dedicated channel for insertion of endoscope with an internal diameter of 14mm and a separate channel for ventilation parallel to it. The endoscopy port ends at the distal tip of the cuff in such a way that it aligns itself to the upper esophageal opening. It also comes with an integrated cuff pressure indicator to monitor the cuff pressure and an adjustable holder with strap to prevent any displacement or dislodgement of the tube. The advantage of LMA Gastro over other SAD is that it facilitates esophageal intubation without compromising the airway and positive pressure ventilation. All ASA1 and ASA2 patients who are posted for elective gastroscopic procedures requiring General anesthesia, after taking an informed consent, will be included in this study. Patient refusal, patients with ASA>= 3, with anticipated difficult airway, high risk of aspiration( morbid obesity BMI > 40), GERD , Cardiac diseases, Airway anomalies, Emergency Gastroscopic procedures will be excluded from the study. All the patients will be recruited by the primary investigator and advised fasting for solids from 12 midnight and clear fluids from 5am. After securing a good intravenous (IV) access and connecting all ASA standard monitors, the patient will be sedated with IV Propofol, following which LMA Gastro will be introduced. The criteria for successful placement of LMA Gastro are: i)Tidal volumes >/= 4ml/kg ii) No peak pressure elevation >30 cm H2o iii)Good EtCo2 waveform in the range of 28-30 iv)Not >/= 3 attempts and bilaterally equal chest rise. Other parameters such as the hemodynamics, saturation, the time taken to wake up the patient and shift to recovery and any occurrence of laryngospasm, airway obstruction or requirement of airway manipulations after removal of LMA Gastro will be monitored during the procedure. In Recovery/Post Anesthesia Care Unit (PACU) patient will be evaluated for any hoarseness in voice or sore throat. The incidence of these parameters will be analyzed and thereby the efficacy of LMA Gastro for Gastroscopic procedures will be evaluated. |