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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name