The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy

NCT05298319 | Completed

• 1 other identifier: Zhejiang Cancer Hospital
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute \[L/min\], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.

Conditions

Hypoxia

Keywords

high flow nasal oxygenation; hypoxemia; bronchoscopy; effective flow

Outcome Measures

Primary Outcomes (1)

• the incidence of hypoxemia

  hypoxemia was defined as SpO2 \< 90%

  during bronchoscopy

Secondary Outcomes (3)

• jaw thrust maneuver

  during bronchoscopy

• increase of flow rate

  during bronchoscopy

• bag-mask ventilation

  during bronchoscopy

Study Arms (6)

Group 1

EXPERIMENTAL

10 L/min of oxygen flow

Device: high flow nasal cannula

Group 2

EXPERIMENTAL

20 L/min of oxygen flow

Device: high flow nasal cannula

Group 3

EXPERIMENTAL

30 L/min of oxygen flow

Device: high flow nasal cannula

Group 4

EXPERIMENTAL

40 L/min of oxygen flow

Device: high flow nasal cannula

Group 5

EXPERIMENTAL

50 L/min of oxygen flow

Device: high flow nasal cannula

Group 6

EXPERIMENTAL

60 L/min of oxygen flow

Device: high flow nasal cannula

Interventions

high flow nasal cannula DEVICE

The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) undergoing sedated bronchoscopy
• (2) 18 to 70 years of age;
• (3) American Society of Anaesthesiologists (ASA) class: I-III

You may not qualify if:

• (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
• (2) severe hypoxemia (SpO2 \< 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
• (3) upper respiratory tract infection or lung infection;
• (4) refusal to participate in this study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Zhang W, Yuan X, Shen Y, Wang J, Xie K, Chen X. Optimal flow of high-flow nasal cannula oxygenation to prevent desaturation during sedation for bronchoscopy: a randomized controlled study. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241246637. doi: 10.1177/17534666241246637.

  PMID: 38659187 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending, principle investigator, department of anesthesiology

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)