- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025215
The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery
August 24, 2021 updated by: The First Affiliated Hospital of Soochow University
Study on the Effect of Precise Aerosol Inhalation Nursing Program on Effective Sputum Excretion in Elderly Patients With Lung Surgery
Comparing the effects of different kinds of aerosol inhalation nursing programs on effective sputum excretion in elderly patients with lung surgery.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Based on the traditional oxygen aerosol inhalation treatment, this study will improve it.
In the process, precise body position care, time control, observation and treatment, evaluation, etc. will be used to form a precise aerosol inhalation care plan.
To explore the effect of this program on effective sputum excretion in elderly patients undergoing lung surgery.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Zhao
- Phone Number: 86-0512-67972216
- Email: zhaojia0327@126.com
Study Locations
-
-
-
Suzhou, China
- Recruiting
- The First Affiliated Hospital of Soochow University
-
Contact:
- Jun Zhao
- Phone Number: 86-0512-67972216
- Email: zhaojia0327@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 79 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- ①Patients with mental illness; ②Acute COPD; ③Serious complications or failure of important organs after operation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Precise
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.
|
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.
|
Experimental: Group B:Traditional
The control group accepts traditional aerosol inhalation nursing method.
This group is planned to enroll 100 patients.
|
The traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardization of aerosol inhalation
Time Frame: From the first to the third day after surgery.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: From the first to the third day after surgery.
|
Discomfort during inhalation: chest tightness, dyspnea, palpitations, elevated blood pressure, etc.
|
From the first to the third day after surgery.
|
Viscosity of sputum
Time Frame: From the first to the third day after surgery.
|
According to the viscosity, the sputum was divided into three types: ⅰ degree (thin phlegm), ⅱ degree (moderate phlegm), ⅲ degree (severe phlegm).
|
From the first to the third day after surgery.
|
Phlegm retention
Time Frame: From the first to the third day after surgery.
|
Sputum sounds can be heard or ausculted at the bedside.
|
From the first to the third day after surgery.
|
Patient satisfaction
Time Frame: The third day after surgery.
|
Likert 5-level scoring method was adopted to allow patients to evaluate the nursing plan.
The higher the score, the more satisfied the patients were.
|
The third day after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jing Luo, The First Affiliated Hospital of Soochow University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2021
Primary Completion (Anticipated)
May 8, 2022
Study Completion (Anticipated)
May 8, 2022
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Actual)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210822
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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