To compare two oxygen device during Gastroendoscopy

Comparison of Nasal Mask and Nasal Cannula During Intravenous Anaesthesia for diagnostic and therapeutic gastrointestinal procedures: A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047907

Enrollment

586

Registered

2022-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: K299- Gastroduodenitis, unspecified

Interventions

Intervention1: Nasal Mask: Patients will be compared for any desaturation on nasal mask during gastrointestinal procedure. Control Intervention1: Nasal Cannula: Patients will be compared for any desat

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing diagnostic or therapeutic gastrointestinal procedures 2.ASA physical status 1 to 4 3.Patients receiving intravenous sedation for the procedures lasting for more than 30 minutes

Exclusion criteria

Exclusion criteria: 1.History of myocardial infarction and unstable angina pectoris within the past 6 months 2.History of severe arrhythmia 3.Acute pharyngitis, and tonsillitis,pneumonia 4.Pulse oxygen saturation (SpO2) 5.Severe obstructive sleep apnea syndrome 6.Allergy to propofol, eggs, soybean, or albumin 7.Lack of cooperation 8.Pregnancy or lactation 9.Participation in other clinical studies within the previous 3 months. Patients who refused to participate were also excluded.

Design outcomes

Primary

Measure	Time frame
The primary outcome is defined as any measurement/occurrence of Spo2 â?¤90% during the procedure.Timepoint: Intraprocedural time	—

Secondary

Measure	Time frame
Occurrence of severe hypoxemia, as Spo2 â?¤ 75% or Spo2 â?¤ 90% for 60 consecutive seconds or longer during the procedure. Duration of hypoxemia and minimum Spo2. The proportion of patients requiring emergency airway management, defined as hypoxemia that could not be corrected by increasing the oxygen flow, but rather needed the jaw-thrust manoeuvre or interruption of the procedure for mask-assisted ventilation, or emergency tracheal intubation. Occurrence of â??other adverse events,â?? a composite outcome including cough, hiccups, nausea and vomiting, reflux, aspiration, and laryngospasm. Patients are classified as experiencing any of these adverse events or none of them. Length of procedure defined as the time from the scope/ probe insertion until its removal. Recovery time, which is defined as the time from the end of the procedure until a score of 5, is achieved on an OAAS, which indicated rapid response to a normal voice. Timepoint: During and after the gastrointestinal procedures	—

Measure

Time frame

Occurrence of severe hypoxemia, as Spo2 â?¤ 75% or Spo2 â?¤ 90% for 60 consecutive seconds or longer during the procedure. Duration of hypoxemia and minimum Spo2. The proportion of patients requiring emergency airway management, defined as hypoxemia that could not be corrected by increasing the oxygen flow, but rather needed the jaw-thrust manoeuvre or interruption of the procedure for mask-assisted ventilation, or emergency tracheal intubation. Occurrence of â??other adverse events,â?? a composite outcome including cough, hiccups, nausea and vomiting, reflux, aspiration, and laryngospasm. Patients are classified as experiencing any of these adverse events or none of them. Length of procedure defined as the time from the scope/ probe insertion until its removal. Recovery time, which is defined as the time from the end of the procedure until a score of 5, is achieved on an OAAS, which indicated rapid response to a normal voice. Timepoint: During and after the gastrointestinal procedures

—

Countries

India

Contacts

Public ContactDr Swati

Indira Gandhi Institute of Medical Sciences Patna

swatipgi2006@gmail.com8544413241

Outcome results

None listed

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