UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000022020 |
| Receipt No. | R000025363 |
| Scientific Title | The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/11/03 (Ver. 4) |
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| Basic information | ||
| Public title | The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients | |
| Acronym | Lung volume during HFNC | |
| Scientific Title | The effect of High Flow Nasal Cannula (HFNC) on end-expiratory lung volume in acute lung injury patients | |
| Scientific Title:Acronym | Lung volume during HFNC | |
| Region |
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| Condition | ||
| Condition | patients with acute lung injury | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To investigate the effect of high flow nasal oxygen therapy on lung volume in the patients with acute lung injury |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | increase in end-expiratory lung volume during HFNC (high flow nasal canula) |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Uncontrolled |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 1 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Aplly HFNC to the patients with ALI and monitor lung volume by EIT (Electrical impedance tomograpy)for 24 hours during HFNC
Evaluate the changes in lung volume with different flow rates of HFNC (10,20,30,40,50L/min) |
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| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1)ALI (Respiratory rate >25/min, SpO2 <96%)
2)Impaired oxygenation with P/F ratio <300mmHg 3)Within 48 hours since diagnose of ALI 4)Written informed consent |
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| Key exclusion criteria | 1)Impaired lung function (COPD grade > 3, or FEV1s < 1000ml)
2)Severly impaired oxgenation with P/F ratio <150mmHg 3)Chronic heart failure (Cardiac index < 1.8L/m2, NYHA > or = 3 ) 4)Unstable hemodynamics (mean arterial pressure < 50mmHg) 5)Glasgow Coma Scale <8 |
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| Target sample size | 20 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Shimane University | ||||||
| Division name | Department of Anesthesiology, Faculty of medicine | ||||||
| Zip code | 6938501 | ||||||
| Address | Enya 89-1, Izumo city, Shimane | ||||||
| TEL | 09094622098 | ||||||
| atsuko929shono@yahoo.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Shimane University | ||||||
| Division name | Department of Anesthesiology, Faculty of medicine | ||||||
| Zip code | 6938501 | ||||||
| Address | Enya 89-1, Izumo city, Shimane | ||||||
| TEL | 09094622098 | ||||||
| Homepage URL | |||||||
| atsuko929shono@yahoo.co.jp | |||||||
| Sponsor | |
| Institute | Enya 89-1, Izumo city, Shimane |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Shimane university |
| Address | Enya-cho 89-1 Izumo |
| Tel | 09094622098 |
| atsuko929shono@yahoo.co.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | none |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | none | ||||||
| Number of participants that the trial has enrolled | 4 | ||||||
| Results | no effect of flow rate on EELV |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | acute lung injury patinets |
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| Participant flow | ALI patients included in the study |
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| Adverse events | none |
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| Outcome measures | no effect of flow rate on EELV |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025363 |
