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A study to assess if addition of a new device like nasopharyngeal airways has any effect in incidence of hypoxemia (low oxygen saturation)

Comparison of the incidence of hypoxemia during sedated gastrointestinal endoscopy: Nasopharyngeal airway with nasal cannula versus nasal cannula alone : A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096079
Enrollment
188
Registered
2025-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: Z038- Encounter for observation for other suspected diseases and conditions ruled out

Interventions

Intervention1: nasopharyngeal airway and nasal cannula: Patients receive oxygen via nasopharyngeal airway and nasal cannula Control Intervention1: Nasal cannula: Patients receive oxygen via only nasal

Sponsors

Varsha Balachandran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing gastrointestinal endoscopy Patients accepted in ASA classification I to III

Exclusion criteria

Exclusion criteria: History of upper respiratory tract infection in the past two weeks Severe chronic obstructive pulmonary disease or acute attack of asthma Baseline oxygen saturation less than 90% when inhaling air History of allergy to eggs, soy, albumin or sedatives Nasal obstruction and cannot effectively inhale oxygen through the nose Congenital anomalies affecting the anatomy of the airways Pregnancy or lactation Glaucoma

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the incidence of hypoxemia during the procedure, defined as SPO2 less than 90. Hypoxemia will be considered clinically significant if the duration of low SPO2 exceeds 1 minute.Timepoint: From induction of sedation to the end of the gastrointestinal endoscopy procedure

Secondary

MeasureTime frame
Any additional measures required to manage hypoxemia, such as increasing oxygen flow or manual ventilation, will be recorded and record adverse events related to sedation or the use of the NPATimepoint: From induction of sedation to the end of the gastrointestinal endoscopy procedure

Countries

India

Contacts

Public ContactGunjan Singh

Armed Forces Medical College

gunjanafmc@gmail.com9612112136

Outcome results

None listed

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