UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011686 |
|---|---|
| Receipt number | R000013586 |
| Scientific Title | The effect of nasal high flow therapy on the recovery of pulmonary function in the early postoperativ period |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2015/03/20 11:04:50 |
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Basic information
Public title
The effect of nasal high flow therapy on the recovery of pulmonary function in the early postoperativ period
Acronym
Nasal high flow therapy and postoperative pulmonary function
Scientific Title
The effect of nasal high flow therapy on the recovery of pulmonary function in the early postoperativ period
Scientific Title:Acronym
Nasal high flow therapy and postoperative pulmonary function
Region
| Japan |
Condition
Condition
Elective surgical patients with cholelithiasis, prostatic cancer, or colon cancer
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In general, pulmonary function has been reported to transiently deteriorate in the early postoperative period. The prolonged impairment of pulmonary function might have an undesirable impact on postoperative recovery in patients undergone abdominal surgery. Nasal high flow (NHF) therapy, which supplies oxygen gases at high flow rate (30-40 L/min) via a large-bore nasal cannula, is able to deliver a low-level positive pressure on peripheral airways. Therefore, NHF therapy is expected to be a preventative respiratory care against alveolar collapse which is one of predisposing factors for the impairment of postoperative pulmonary function. We investigate whether an early introduction of NHF therapy enhance a recovery in postoperative pulmonary function comparing with a conventional nasal oxygen cannula.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory parameters including vital capacity and forced expiratory volume one second percent measured at 4 time points (0, 6, 24, and 48 hours after the completion of surgery).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After full recovery of consciousness from general anesthesia, all surgical patients are transferred to the post-anesthetic care room. They receive oxygen supply of 5 l/min via a nasal cannula and are stabilized for 30 minutes. Then, they take a pulmonary function test at sitting position for the measurement of respiratory parameters such as %VC and %FEV1.0 as control values. Aftre they return to a general surgical ward, they are randomly allocated to either a control or an interventional group. Patients in a control group consecutively receive oxygen supply of 5 l/min via a nasal cannula, and other patients in an interventional group receive NHF therapy at 40 l/min of 50% oxygen via a large-bore nasal cannula. All patients take a pulmonary function test at 6, 24, and 48 hours after surgery. Oxygen supply is discontinued in 2 groups in the next morning.
Interventions/Control_2
After full recovery of consciousness from general anesthesia, all surgical patients are transferred to the post-anesthetic care room. They receive oxygen supply of 5 l/min via a nasal cannula and are stabilized for 30 minutes. Then, they take a pulmonary function test at sitting position for the measurement of respiratory parameters such as %VC and %FEV1.0 as control values. After they return to a general surgical ward, they are randomly allocated to either a control or an interventional group. Patients in a control group consecutively receive oxygen supply of 5 l/min via a nasal cannula, and other patients in an interventional group receive NHF therapy at 40 l/min of 50% oxygen via a large-bore nasal cannula. All patients take a pulmonary function test at 6, 24, and 48 hours after surgery. Oxygen supply is discontinued in 2 groups in the next morning.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients aged from 20 to 75 years old
Elective surgical patients scheduled to undergo laparoscopic surgery of cholecystectomy, total prostatectomy, or resection of colon
Physical status of American Society of Anesthesiologists 1 to 2
Key exclusion criteria
Impossible to take a pulmonary function test because of postoperative delirium, or severe pain
The proposal surgical procedure is not performed
(for example, alternation from laparoscopic to open surgery)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Takasaki |
Organization
Uwajima city hospital
Division name
Department of Anesthesia
Zip code
Address
1-1 Goten-machi Uwajima Ehime
TEL
0895-25-1111
ytakasak@uwajima-mh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takasaki |
Organization
Uwajima city hospital
Division name
Department of Anesthesia
Zip code
Address
1-1 Goten-machi Uwajima Ehime
TEL
0895-25-1111
Homepage URL
ytakasak@uwajima-mh.jp
Sponsor or person
Institute
Uwajima city hospital
Institute
Department
Personal name
Funding Source
Organization
Uwajima city hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2015 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013586
