NCT05025215

Brief Summary

Comparing the effects of different kinds of aerosol inhalation nursing programs on effective sputum excretion in elderly patients with lung surgery.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

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

May 8, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 24, 2021

Last Update Submit

August 24, 2021

Conditions

Inhalation

Outcome Measures

Primary Outcomes (1)

  • Standardization of aerosol inhalation

    The investigators use a self-made inhalation implementation standard evaluation form to evaluate whether inhalation was standard in postoperative patients.

    From the first to the third day after surgery.

Secondary Outcomes (4)

  • Adverse events

    From the first to the third day after surgery.

  • Viscosity of sputum

    From the first to the third day after surgery.

  • Phlegm retention

    From the first to the third day after surgery.

  • Patient satisfaction

    The third day after surgery.

Study Arms (2)

Group A： Precise

EXPERIMENTAL

The experimental group accepts improved precise aerosol inhalation nursing program，which was based on the traditional oxygen aerosol inhalation treatment, including precise body position care, time control, observation and treatment, evaluation, etc. This group is planned to enroll 100 patients.

Behavioral: Precise Aerosol Inhalation Nursing Program

Group B：Traditional

EXPERIMENTAL

The control group accepts traditional aerosol inhalation nursing method. This group is planned to enroll 100 patients.

Behavioral: Traditional Aerosol Inhalation Nursing Method

Interventions

Precise Aerosol Inhalation Nursing ProgramBEHAVIORAL

The precise aerosol inhalation nursing program was based on the traditional oxygen aerosol inhalation treatment, including precise body position care, time control, observation and treatment, evaluation, etc.

Group A： Precise
Traditional Aerosol Inhalation Nursing MethodBEHAVIORAL

The traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation.

Group B：Traditional

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ①The patient underwent thoracoscopic lung surgery; ②There was no obvious pulmonary infection before the operation; ③Good audiovisual function, no communication barriers, able to cooperate with nebulized inhalation operation; ④Patients informed consent to this study.

You may not qualify if:

  • ①Patients with mental illness; ②Acute COPD; ③Serious complications or failure of important organs after operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Related Publications (9)

  • Bosnic-Anticevich SZ, Sinha H, So S, Reddel HK. Metered-dose inhaler technique: the effect of two educational interventions delivered in community pharmacy over time. J Asthma. 2010 Apr;47(3):251-6. doi: 10.3109/02770900903580843.

    PMID: 20394511BACKGROUND

  • Press VG, Kelly CA, Kim JJ, White SR, Meltzer DO, Arora VM. Virtual Teach-To-Goal Adaptive Learning of Inhaler Technique for Inpatients with Asthma or COPD. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1032-1039.e1. doi: 10.1016/j.jaip.2016.11.018. Epub 2017 Jan 5.

    PMID: 28065689BACKGROUND

  • Pedersen S, Ostergaard PA. Nasal inhalation as a cause of inefficient pulmonal aerosol inhalation technique in children. Allergy. 1983 Apr;38(3):191-4. doi: 10.1111/j.1398-9995.1983.tb01605.x.

    PMID: 6846746BACKGROUND

  • Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care. 2005 Oct;50(10):1360-74; discussion 1374-5.

    PMID: 16185371BACKGROUND

  • Klijn SL, Hiligsmann M, Evers SMAA, Roman-Rodriguez M, van der Molen T, van Boven JFM. Effectiveness and success factors of educational inhaler technique interventions in asthma & COPD patients: a systematic review. NPJ Prim Care Respir Med. 2017 Apr 13;27(1):24. doi: 10.1038/s41533-017-0022-1.

    PMID: 28408742BACKGROUND

  • Wu M, Woodrick NM, Arora VM, Farnan JM, Press VG. Developing a Virtual Teach-To-Goal Inhaler Technique Learning Module: A Mixed Methods Approach. J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1728-1736. doi: 10.1016/j.jaip.2017.04.032. Epub 2017 Jun 7.

    PMID: 28600133BACKGROUND

  • Price DB, Roman-Rodriguez M, McQueen RB, Bosnic-Anticevich S, Carter V, Gruffydd-Jones K, Haughney J, Henrichsen S, Hutton C, Infantino A, Lavorini F, Law LM, Lisspers K, Papi A, Ryan D, Stallberg B, van der Molen T, Chrystyn H. Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1071-1081.e9. doi: 10.1016/j.jaip.2017.01.004. Epub 2017 Mar 9.

    PMID: 28286157BACKGROUND

  • Press VG, Arora VM, Trela KC, Adhikari R, Zadravecz FJ, Liao C, Naureckas E, White SR, Meltzer DO, Krishnan JA. Effectiveness of Interventions to Teach Metered-Dose and Diskus Inhaler Techniques. A Randomized Trial. Ann Am Thorac Soc. 2016 Jun;13(6):816-24. doi: 10.1513/AnnalsATS.201509-603OC.

    PMID: 26998961BACKGROUND

  • Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.

    PMID: 22592354BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Luo

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhao

CONTACT

86-0512-67972216zhaojia0327@126.com

Study Design

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

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 27, 2021

Study Start

May 8, 2021

Primary Completion

May 8, 2022

Study Completion

May 8, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)