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International and observational study to understand the medical procedures performed to prevent and relieve airway obstruction during surgery

International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) - Nil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061977
Enrollment
10500
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NA Control Intervention1: NIL: NA

Sponsors

Università degli Studi di Torino
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients undergoing advanced airway management (either tracheal intubation or supraglottic airway device, SGA placement) for general anaesthesia in the operating room (OR) or non-operating room (NORA) locations

Exclusion criteria

Exclusion criteria: 1. Airway management during cardiopulmonary resuscitation. 2. Critically ill patients undergoing advanced airway management due to their underlying clinical condition.

Design outcomes

Primary

MeasureTime frame
At least one of the following major adverse events during airway management occurring within 30 minutes from induction or up to surgical incision 1. Severe hypoxia (SpO2 less than 80 percentage) 2. Cardiovascular collapse (at least one of the following) a. Systolic arterial pressure less than 65 mmHg b. Systolic arterial pressure less than 90 mmHg for more than 15 minutes c. Unplanned need of vasopressors or fluid load more than 15 ml per kg to maintain the target blood pressureTimepoint: within 30 minutes from induction or up to surgical incision

Secondary

MeasureTime frame
1. Minor adverse events during airway management o Moderate hypoxia (SpO2 less than 93percent) o Airway injury o Clinically relevant bleeding o Oral aspiration of gastric contents o Dental injury 2. Difficult facemask ventilation 3. First pass success rate Timepoint: within 30 minutes from induction or up to surgical incision

Countries

Australia, Croatia, France, India, Ireland, Italy, Turkey, United Kingdom, United States of America

Contacts

Public ContactDr Sheila Nainan Myatra

Tata Memorial Hospital

sheila150@hotmail.com9820156070

Outcome results

None listed

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