| CTRI Number |
CTRI/2025/07/092116 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study of air entry in stomach with an inserted and removed gastric tube using heat elasticity cuffed airway devices in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
Evaluation of Gastric Insufflation with and without an inserted gastric tube in Thermoelastic cuff supraglottic devices: A Randomised Controlled Crossover Study |
| Trial Acronym |
SIGTTAD (Study of Insufflation with/without Gastric Tube in Thermoelastic Airway Devices ) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrThrisha Sajeeth |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8867110889 |
| Fax |
|
| Email |
thrishasajeeth30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Chaudhary |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room NO.313,Department of Anesthesiology, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9871262699 |
| Fax |
|
| Email |
kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrThrisha Sajeeth |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8867110889 |
| Fax |
|
| Email |
thrishasajeeth30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi-110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak and Associated Hopsitals |
| Address |
Department of Anesthesiology and Critical Care, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals , New Delhi-110002 |
| 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 |
| DrThrisha Sajeeth |
Lok Nayak Hospital, New Delhi |
OT Block, Department of Anaesthesiology,Maulana Azad Medical College and associated Lok Nayak, G.I.P.M.E.R and G.N.E.C Hospitals,2 Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI |
8867110889
thrishasajeeth30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: C00-D49||Neoplasms, (5) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (6) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inserted Gastric tube |
Gastric insufflation with inserted gastric tube will be measured using gastric ultrasound at five different time points in thermoelastic cuff supraglottic airway devices
1. Pre operatively (baseline)
2. Before start of first incremental positive airway pressure trial
3. After completion of first incremental positive airway pressure trial
4. Before start of second incremental positive airway pressure trial
5. After completion of second incremental positive airway pressure trial |
| Comparator Agent |
Non-inserted gastric tube |
Gastric insufflation without an inserted gastric tube will be measured using gastric ultrasound at five different time points in thermoelastic cuff supraglottic airway devices
1. Pre operatively (baseline)
2. Before start of first incremental positive airway pressure trial
3. After completion of first incremental positive airway pressure trial
4. Before start of second incremental positive airway pressure trial
5. After completion of second incremental positive airway pressure trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists(ASA) Physical Status 1,2,3 |
|
| ExclusionCriteria |
| Details |
1.Gastroesophageal reflux disease
2.Previous surgery on the upper gastrointestinal tract
3.Uncontrolled diabetes, severe pulmonary, end stage kidney or neurodegenerative diseases
4.Known airway diseases or anticipated difficult airway
5.Pregnancy
6.BMI more than or equal to 35 kg/m2
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of gastric insufflation with and without an inserted gastric tube during incremental peak airway pressure trial (PAP)in thermoelastic cuff supraglottic devices. |
1. Pre operatively (baseline)
2. Before start of first incremental positive airway pressure trial (approximately 8-10 mins after entering the operation theatre)
3. After completion of first incremental positive airway pressure trial
4. Before start of second incremental positive airway pressure trial
5. After completion of second incremental positive airway pressure trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in cross sectional area of gastric antrum during the incremental peak airway pressure trial. |
1. Pre operatively (baseline)
2. Before start of first incremental positive airway pressure trial
3. After completion of first incremental positive airway pressure trial
4. Before start of second incremental positive airway pressure trial
5. After completion of second incremental positive airway pressure trial |
| Mean oropharyngeal leak pressure with & without an inserted gastric tube. |
After completion of second incremental positive airway pressure trial |
| subjective ease of insertion of thermoelastic cuff supraglottic devices. |
After insertion of thermoelastic cuff supraglottic devices |
| first attempt insertion success rate of thermoelastic cuff supraglottic devices. |
After first attempt of insertion of thermoelastic cuff supraglottic devices |
| subjective ease of gastric tube insertion |
After insertion of gastric tube |
| complications like post operative nausea & vomiting (PONV), pharyngeal discomfort, blood staining of the device, if any |
at the end of stay in Post Anesthesia Care Unit & One week after surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Second Generation Supraglottic devices (SGD’s) are commonly used nowadays. They are considered superior to first generation devices due to higher oropharyngeal leak pressure, higher hypopharyngeal leak pressure and improved placement success. An additional lumen provides a mean for inserting a gastric tube as it is assumed that the risk of aspiration could be reduced by gastric drainage via such tube. Inserted gastric tube ensures proper positioning of SGD’s and hence reduce gastric insufflation. By contrast an open gastric channel venting air from the upper esophagus could protect against gastric insufflation. Gastric insufflation plays a key role in the pathophysiology of aspiration which can be carefully stimulated and detected reliably with gastric ultrasound. In our study we aim to evaluate and compare gastric insufflation with and without an inserted gastric tube though the available thermoelastic cuff supraglottic devices. |