InhalationNCT05025215
The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery
A study testing Precise Aerosol Inhalation Nursing Program and Traditional Aerosol Inhalation Nursing Method in people with Inhalation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Comparing the effects of different kinds of aerosol inhalation nursing programs on effective sputum excretion in elderly patients with lung surgery. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Inhalation
- What is being tested?
- Precise Aerosol Inhalation Nursing Program and Traditional Aerosol Inhalation Nursing Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2021to 8 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- ①Patients with mental illness; ②Acute COPD; ③Serious complications or failure of important organs after operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Jun Zhao, 86-0512-67972216, zhaojia0327@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Inhalation
- Being tested
- Precise Aerosol Inhalation Nursing Program, Traditional Aerosol Inhalation Nursing Method
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precise Aerosol Inhalation Nursing ProgramBehavioural
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.
Traditional Aerosol Inhalation Nursing MethodBehavioural
The traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Aerosol Inhalation Nursing Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardization of aerosol inhalation
The investigators use a self-made inhalation implementation standard evaluation form to evaluate whether inhalation was standard in postoperative patients.
Measured: From the first to the third day after surgery.
Secondary outcomes (4)
Adverse events
Discomfort during inhalation: chest tightness, dyspnea, palpitations, elevated blood pressure, etc.
Measured: From the first to the third day after surgery.
Viscosity of sputum
According to the viscosity, the sputum was divided into three types: ⅰ degree (thin phlegm), ⅱ degree (moderate phlegm), ⅲ degree (severe phlegm).
Measured: From the first to the third day after surgery.
Phlegm retention
Sputum sounds can be heard or ausculted at the bedside.
Measured: From the first to the third day after surgery.
Patient satisfaction
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.
Measured: The third day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start8 May 2021
- Primary completion8 May 2022 (estimated)
- Study completion8 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InhalationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Luo, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025215
- Sponsor's protocol ID
- 20210822
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20394511Press 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.
PubMed 28065689Pedersen 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.
PubMed 6846746Fink 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.
PubMed 16185371Klijn 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.
PubMed 28408742Wu 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.
PubMed 28600133Price 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.
PubMed 28286157Press 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.
PubMed 26998961Press 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.
PubMed 22592354
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Precise Aerosol Inhalation Nursing Program on Effective Sputum Excretion in Elderly Patients With Lung Surgery
- ClinicalTrials.gov ID
- NCT05025215
- Acronym / sponsor ID
- 20210822
- Conditions
- Inhalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 8 May 2021 (actual)
- Primary completion
- 8 May 2022 (estimated)
- Study completion
- 8 May 2022 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the effects of different kinds of aerosol inhalation nursing programs on effective sputum excretion in elderly patients with lung surgery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A： Precise | Experimental | Behavioral: Precise Aerosol Inhalation Nursing ProgramThe 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. |
| Group B：Traditional | Experimental | Behavioral: Traditional Aerosol Inhalation Nursing MethodThe control group accepts traditional aerosol inhalation nursing method. This group is planned to enroll 100 patients. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- ①Patients with mental illness; ②Acute COPD; ③Serious complications or failure of important organs after operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precise Aerosol Inhalation Nursing ProgramThe 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. | Behavioural | Group A： Precise |
| Traditional Aerosol Inhalation Nursing MethodThe traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation. | Behavioural | Group B：Traditional |
Primary outcome
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.
4 secondary outcomes
Adverse events
Time frame: From the first to the third day after surgery.
Viscosity of sputum
Time frame: From the first to the third day after surgery.
Phlegm retention
Time frame: From the first to the third day after surgery.
Patient satisfaction
Time frame: The third day after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 20394511Bosnic-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.
- Background: PubMed 28065689Press 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.
- Background: PubMed 6846746Pedersen 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.
- Background: PubMed 16185371Fink 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.
- Background: PubMed 28408742Klijn 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.
- Background: PubMed 28600133Wu 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.
- Background: PubMed 28286157Price 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.
- Background: PubMed 26998961Press 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.
- Background: PubMed 22592354Press 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.
- Individual participant dataSharing planned: No
Related trials for Inhalation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Luo principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precise Aerosol Inhalation Nursing Program and Traditional Aerosol Inhalation Nursing Method in people with Inhalation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhao (86-0512-67972216, zhaojia0327@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardization of aerosol inhalation (time frame: From the first to the third day after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025215, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.