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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

Evaluation of Gastric Insufflation with and without an inserted gastric tube in Thermoelastic cuff supraglottic devices: A Randomised Controlled Crossover Study - SIGTTAD (Study of Insufflation with/without Gastric Tube in Thermoelastic Airway Devices )

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/092116
Enrollment
100
Registered
2025-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: H60-H95- Diseases of the ear and mastoid process Health Condition 3: N00-N99- Diseases of the genitourinary system Health Condition 4: C00-D49- Neoplasms Health Condition 5: L00-L99- Diseases of the skin and subcutaneous tissue Health Condition 6: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: 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

Sponsors

Maulana Azad Medical College and Lok Nayak and Associated Hopsitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists(ASA) Physical Status 1,2,3

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Incidence of gastric insufflation with and without an inserted gastric tube during incremental peak airway pressure trial (PAP)in thermoelastic cuff supraglottic devices.Timepoint: 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

MeasureTime frame
change in cross sectional area of gastric antrum during the incremental peak airway pressure trial.Timepoint: 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.Timepoint: After completion of second incremental positive airway pressure trial;subjective ease of insertion of thermoelastic cuff supraglottic devices.Timepoint: After insertion of thermoelastic cuff supraglottic devices;first attempt insertion success rate of thermoelastic cuff supraglottic devices.Timepoint: After first attempt of insertion of thermoelastic cuff supraglottic devices;subjective ease of gastric tube insertionTimepoint: After insertion of gastric tube;complications like post operative nausea & vomiting (PONV), pharyngeal discomfort, blood staining of the device, if anyTimepoint: at the end of stay in Post Anesthesia Care Unit & One week after surgery

Countries

India

Contacts

Public ContactDrThrisha Sajeeth

Maulana Azad Medical College

kapsdr@yahoo.com9871262699

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026