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The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery

Primary Purpose

Inhalation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Precise Aerosol Inhalation Nursing Program
Traditional Aerosol Inhalation Nursing Method
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inhalation

Eligibility Criteria

65 Years - 79 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A： Precise

Group B：Traditional

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events
Discomfort during inhalation: chest tightness, dyspnea, palpitations, elevated blood pressure, etc.
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).
Phlegm retention
Sputum sounds can be heard or ausculted at the bedside.
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.

Full Information

First Posted
August 24, 2021
Last Updated
August 24, 2021
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05025215
Brief Title
The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery
Official Title
Study on the Effect of Precise Aerosol Inhalation Nursing Program on Effective Sputum Excretion in Elderly Patients With Lung Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2021 (Actual)
Primary Completion Date
May 8, 2022 (Anticipated)
Study Completion Date
May 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A： Precise
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B：Traditional
Arm Type
Experimental
Arm Description
The control group accepts traditional aerosol inhalation nursing method. This group is planned to enroll 100 patients.
Intervention Type
Behavioral
Intervention Name(s)
Precise Aerosol Inhalation Nursing Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Aerosol Inhalation Nursing Method
Intervention Description
The traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation.
Primary Outcome Measure Information:
Title
Standardization of aerosol inhalation
Description
The investigators use a self-made inhalation implementation standard evaluation form to evaluate whether inhalation was standard in postoperative patients.
Time Frame
From the first to the third day after surgery.
Secondary Outcome Measure Information:
Title
Adverse events
Description
Discomfort during inhalation: chest tightness, dyspnea, palpitations, elevated blood pressure, etc.
Time Frame
From the first to the third day after surgery.
Title
Viscosity of sputum
Description
According to the viscosity, the sputum was divided into three types: ⅰ degree (thin phlegm), ⅱ degree (moderate phlegm), ⅲ degree (severe phlegm).
Time Frame
From the first to the third day after surgery.
Title
Phlegm retention
Description
Sputum sounds can be heard or ausculted at the bedside.
Time Frame
From the first to the third day after surgery.
Title
Patient satisfaction
Description
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.
Time Frame
The third day after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhao
Phone
86-0512-67972216
Email
zhaojia0327@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Luo
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhao
Phone
86-0512-67972216
Email
zhaojia0327@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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20394511
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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The Effect of Precise Aerosol Inhalation Nursing on Sputum Excretion in Elderly Patients With Lung Surgery

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