NCT03019354

Brief Summary

In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It has physiological effects: reduction of anatomical dead space, positive end expiratory pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 30, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

January 10, 2017

Last Update Submit

May 28, 2018

Conditions

Pulmonary AtelectasesLung InjuryGeneral Anesthesia

Keywords

high flow oxygenpulmonary atelectasisintravenous general anesthesia

Outcome Measures

Primary Outcomes (1)

  • Chest CT image atelectatic area

    lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.

    At the end of surgery

Secondary Outcomes (2)

  • postoperative pulmonary complications

    within the first 7 days after surgery

  • lung injury

    At the end of surgery

Other Outcomes (2)

  • Respiratory gas exchange function

    At the end of surgery

  • need for supplemental oxygen therapy

    within the first 7 days after surgery

Study Arms (2)

high-flow nasal oxygen

EXPERIMENTAL

high-flow nasal oxygen was used during intravenous general anesthesia

Device: high-flow nasal oxygen

Oxygen mask

ACTIVE COMPARATOR

oxygen mask was used during intravenous general anesthesia

Device: Oxygen mask

Interventions

high-flow nasal oxygenDEVICE

Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.

Also known as: High-flow nasal cannula
high-flow nasal oxygen
Oxygen maskDEVICE

Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.

Oxygen mask

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hepatic tumor undergoing CT guided radiofrequency ablation
  • Age \> 20 years old

You may not qualify if:

  • Cardiac dysfunction, such as heart failure \> NYHA class II, coronary arterial disease
  • Impaired renal function, cGFR\< 60 ml/min/1.73 m2
  • Pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

Related Publications (1)

  • Shih CC, Liang PC, Chuang YH, Huang YJ, Lin PJ, Wu CY. Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1025-1031. doi: 10.1097/EJA.0000000000001324.

    PMID: 32890016DERIVED

MeSH Terms

Conditions

Pulmonary AtelectasisLung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Chun-Yu Wu, MD,PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Chih Shih, MD

CONTACT

+886 911674300s6319138@gmail.com

Chung-Chih Shih, MD

CONTACT

+886 972653379s6319138@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)