UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041330
Receipt number R000047182
Scientific Title Optimal dose of normal saline injection to detect correct peripheral venous catheter placement with precordial Doppler ultrasonography: a randomized interventional study
Date of disclosure of the study information 2020/09/01
Last modified on 2022/04/21 22:02:10

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Basic information

Public title

Optimal dose of normal saline injection to detect correct peripheral venous catheter placement with precordial Doppler ultrasound: a randomized interventional study

Acronym

Optimal dose of normal saline injection to detect correct peripheral venous catheter placement with precordial Doppler ultrasound

Scientific Title

Optimal dose of normal saline injection to detect correct peripheral venous catheter placement with precordial Doppler ultrasonography: a randomized interventional study

Scientific Title:Acronym

Optimal dose of normal saline injection to detect correct peripheral venous catheter placement with precordial Doppler ultrasound

Region

Japan


Condition

Condition

Patients with elective surgeries in good health conditions

Classification by specialty

Anesthesiology Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims at evaluating the optimal dose and speed of normal saline injection to detect the correct placement of peripheral intravenous lines.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subjective judgement in predefined Doppler sound change (dichotomous outcome), the difference of blood flow velocity on precordial Doppler ultrasonography before and after injecting a bolus of normal saline

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

1 bolus of normal saline will be administered in the operating rooms. 0.1mL/kg of a normal saline bolus (intervention 1) will be administered via peripheral intravenous lines.

Interventions/Control_2

1 bolus of normal saline will be administered in the operating rooms and post-anesthesia care unit. 0.3mL/kg (intervention 2) of a normal saline bolus will be administered via peripheral intravenous lines.

Interventions/Control_3

1 bolus of normal saline will be administered in the operating rooms. 0.5mL/kg of a normal saline bolus (control) will be administered via peripheral intravenous lines.

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

1 years-old <=

Age-upper limit

6 years-old >=

Gender

Male and Female

Key inclusion criteria

Elective surgical patients who are planned to be observed at post-anesthesia care unit postoperatively, American society of anesthesiology physical status (ASA) 1 or 2, age is equal of less than 6 years old, weight is between 10 - 20 kg (includes 10 and 20 kg)

Key exclusion criteria

Anemia: Hb is less than 10 g/dL
On diuretics with a diagnosis of congestive heart failure
Abnormal values of electrolytes: Na is less than 135 mEq/L, Na is more than 147 mEq/L, Cl is less than 98 mEq/L, Cl is more than 110 mEq/L, or on treatments

Target sample size

330


Research contact person

Name of lead principal investigator

1st name Taiki
Middle name
Last name Kojima

Organization

Aichi children's general health and medical center

Division name

Anesthesiology

Zip code

474-8710

Address

Morioka-cho 7-chome 426, Obu city, Aich, Japan

TEL

0562-43-0500

Email

daiki_kojima@sk00106.achmc.pref.aichi.jp


Public contact

Name of contact person

1st name Taiki
Middle name
Last name Kojima

Organization

Aichi children's general health and medical center

Division name

Anesthesiology

Zip code

474-8710

Address

Morioka-cho 7-chome 426, Obu city, Aich, Japan

TEL

0562-43-0500

Homepage URL


Email

daiki_kojima@sk00106.achmc.pref.aichi.jp


Sponsor or person

Institute

Aichi children's general health and medical center, department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

None

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

Aichi children's general health and medical center

Address

Morioka-cho 7-chome 426, Obu city, Aich, Japan

Tel

0562-43-0500

Email

rinsyoukenkyu@sk00106.achmc.pref.aichi.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

あいち小児保健医療総合センター(愛知県)


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 01 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

Completed

Date of protocol fixation

2020 Year 03 Month 19 Day

Date of IRB

2020 Year 08 Month 28 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 15 Day

Date of closure to data entry

2022 Year 04 Month 01 Day

Date trial data considered complete

2022 Year 04 Month 05 Day

Date analysis concluded

2022 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 06 Day

Last modified on

2022 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047182


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name