Comparison of Hypoxia Between HFNC and SNC in Patient Undergoing UGI Endoscopic Procedures in Deep Sedation

NCT06482879 | Completed FDA Device

• 1 other identifier: NamsAnuj
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. The high-flow nasal cannula, capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 l/min, offers additional benefits, including positive end-expiratory pressure and reduced dead space. We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation. This was prospective, comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia (SpO2 \< 92%) and secondary objectives were to compare interruption of procedure due to hypoxia, minimum hypoxia level and episodes of hypoxia between high flow nasal canula (flow rate of 30l/min with FiO2 of 0.5) and simple nasal canula (flow rate of 6l/min) in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion. The study comprised 125 participants, 58 in simple nasal canula and 67 in high flow nasal cannula group. The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups, with rates of 37.3% (22/58) and 16.4% (11/67), respectively. The relative risk (RR) of hypoxia was 0.43 (95% CI: 0.23-0.81), with a p-value of 0.009. Procedural interruptions due to hypoxia occurred in 8.6% (5/58) of participants in the simple nasal cannula group and 4.47% (3/67) in the high flow nasal cannula group, with RR of 0.17 (95% CI: 0.02-1.41) and a p-value 0.1. Furthermore, the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group (5 vs. 0), with a p-value \< 0.001.The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula.

Conditions

Hypoxia

Keywords

hypoxia, oxygen delivery device

Outcome Measures

Primary Outcomes (1)

• Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula

  During the procedure

Secondary Outcomes (2)

• Comparison of frequency of hypoxia between high flow nasal canula and Simple nasal canula

  During the procedure

• Comparison of interruption of procedure between high flow nasal canula and Simple nasal canula

  During the procedure

Study Arms (2)

High flow nasal canula

Patient undergoing upper GI endoscopic procedure under deep sedation will receive high flow nasal canula.

Device: Oxygen delivery

Simple nasal canula

Patient undergoing upper GI endoscopic procedure under deep sedation will receive simple nasal canula.

Device: Oxygen delivery

Interventions

Oxygen delivery DEVICE

Oxygen is delivered with high flow nasal canula or simple nasal canula to prevent hypoxia during procedures under deep sedation.

High flow nasal canula; Simple nasal canula

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion in tertiary care hospital of Nepal.

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Study Sites (1)

Anuj Jung Karki

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 20, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

NE (1)