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Completed

NCT Number: NCT05298319

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • (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.

Treatment and study plan

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.

Primary outcomes

  1. the incidence of hypoxemia

    Time frame: during bronchoscopy

    hypoxemia was defined as SpO2 < 90%

Secondary outcomes

  1. jaw thrust maneuver

    Time frame: during bronchoscopy

    percentage of jaw thrust maneuver

  2. increase of flow rate

    Time frame: during bronchoscopy

    percentage of increase of flow rate

  3. bag-mask ventilation

    Time frame: during bronchoscopy

    percentage of bag-mask ventilation

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy

Acronym: HFNO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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