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Do not forget the lungs: I/E mode physiotherapy for people recovering from COVID-19. Preliminary feasibility study
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注册号：

Registration number：

 ChiCTR2100048830 

最近更新日期：

Date of Last Refreshed on：

 2021-07-18 

注册时间：

Date of Registration：

2021-07-18 

注册号状态：

补注册  

Registration Status：

Retrospective registration  

注册题目：

Antonello NICOLINI: please submit an approval letter of IRB Do not forget the lungs: I/E mode physiotherapy for people recovering from COVID-19. Preliminary feasibility  

Public title：

Do not forget the lungs: I/E mode physiotherapy for people recovering from COVID-19. Preliminary feasibility study  

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Do not forget the lungs: I/E mode physiotherapy for people recovering from COVID-19. Preliminary feasibility study  

Scientific title：

Do not forget the lungs: I/E mode physiotherapy for people recovering from COVID-19. Preliminary feasibility study  

研究课题代号(代码)：

Study subject ID：

 

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

 

申请注册联系人：

Antonello NICOLINI 

研究负责人：

Bruna GRECCHI 

Applicant：

Antonello NICOLINI 

Study leader：

Bruna GRECCHI 

申请注册联系人电话：

Applicant telephone：

00393495952294 

研究负责人电话：

Study leader's telephone：

00393498448047 

申请注册联系人传真 ：

Applicant Fax：

 

研究负责人传真：

Study leader's fax：

 

申请注册联系人电子邮件：

Applicant E-mail：

antonellonicolini@gmail.com 

研究负责人电子邮件：

Study leader's E-mail：

bruna.grecchi14@gmail.com 

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 

申请注册联系人通讯地址：

sestri levante via terzi 47 italy 

研究负责人通讯地址：

sestri levante via terzi 47 italy 

Applicant address：

sestri levante via terzi 47 italy 

Study leader's address：

sestri levante via terzi 47 italy 

申请注册联系人邮政编码：

Applicant postcode：

16039 

研究负责人邮政编码：

Study leader's postcode：

 

申请人所在单位：

意大利Genoa sestri levante 

Applicant's institution：

respiratory diseases unit 

是否获伦理委员会批准：

否 

Approved by ethic committee：

NO 

伦理委员会批件文号：

Approved No. of ethic committee：

 

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

 

Name of the ethic committee：

 

伦理委员会批准日期：

Date of approved by ethic committee：

2013-08-26 

伦理委员会联系人：

 

Contact Name of the ethic committee：

 

伦理委员会联系地址：

 

Contact Address of the ethic committee：

 

伦理委员会联系人电话：

Contact phone of the ethic committee：

 

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 

研究实施负责（组长）单位：

asl4 chiavarese chiavari 

Primary sponsor：

asl4 chiavarese chiavari 

研究实施负责（组长）单位地址：

via gb ghio 9 chiavari italy 

Primary sponsor's address：

via gb ghio 9 chiavari italy 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

italy

Province：

genoa

City：

sestri levante

单位(医院)：

具体地址：

Institution
hospital：

respiratory diseases unit

Address：

via terzi 47

经费或物资来源：

no founding sources 

Source(s) of funding：

no founding sources 

研究疾病：

post covid 19 syndrome 

Target disease：

post covid 19 syndrome 

研究疾病代码：

 

Target disease code：

 

研究类型：

干预性研究 

Study type：

Interventional study 

研究所处阶段：

回顾性研究 

Study phase：

Retrospective study 

研究目的：

evaluation of respiratory function parameters quality of life scores exercise capacity befora and after teatment with T-PEP 4 in patients with post COVID 19 syndrome 

Objectives of Study：

evaluation of respiratory function parameters quality of life scores exercise capacity befora and after teatment with T-PEP 4 in patients with post COVID 19 syndrome 

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Setting This observational preliminary study was conducted from December 2020 to April 2021. Subjects were recruited consecutively within the first 4 weeks from hospital discharge. All the patients were admitted because of acute respiratory failure due to Sars CoV2 related pneumonia (1). The study was carried out at Covid Centre of Hospital of Sestri Levante. The study was approved by Local Ethics Committee, registered at Chinese Clinical Trial ( reg n° ) and was performed following Helsinki Declaration. Every patient gave written informed consent. Inclusion criteria: - Age ≥ 18 - Discharged from hospital after a COVID19 pneumonia - In spontaneous breathing - Able to breathe keeping a mouthpiece - Mild to moderate obstructive syndrome at spirometry (12) and at least one symptom among: - Breathlessness or feeling as “I can't take a deep breath” or inability to yawn - Cough - Chest pain/Chest tightness - Dyspnoea (at rest or during normal ADL) - Oxygen desaturation ≥4% during daily physical activities Exclusion criteria: - Already on treatment with NIV or CPAP before COVID 19 - Oxygen supplementation at rest - Inability or refusal to collaborate - Lack of informed consent - Severe obstructive syndrome ( forced expiratory volume 1 second - FEV1 - < 50% ) ? Device For the purpose of this study, we tested the inspiratory/expiratory (I/E mode) function of temporary positive expiratory pressure TPEP?4 medical device (Medical Product Research – Legnano, Italy) ( fig.1a ). TPEP? is a patented technology firstly aimed to enhance the airways clearance : during the active expiration in an open circuit, a temporary oscillating counter-flow produces a positive expiratory pressure (TPEP) of 1 cm/H2O, lasting for most of the expiratory phase. Patient is asked to hold on the TPEP counter-flow as long as possible, actually increasing Vt and sustaining the expiratory flow for a longer time. Whereas, the I/E mode is an advanced feature aimed to drive the patient breath by breath in an active and gentle lung recruitment. By using visual targets on a display, expiratory and/or inspiratory flow-dependent resistances, the I/E mode helps the patient to perform cycles of slow and deep inspiration, tele-inspiratory pause and slow expiration. [Fig1 b) TPEP circuit, b) I/E mode circuit]. The “time adaptation” calculates the mean time of previous inspiratory/expiratory efforts, indicating with red (below average time) or green (equal to or greater than the average) numbers the I/E time and encouraging the patient to improve the performance breath by breath. Initial test and set-up The circuit was assembled as shown in Fig. 1b. A unidirectional two-way valve was positioned at the end of the standard TPEP circuit, after the antibacterial filter, to allows the positioning of flow-dependent resistors. The “I/E mode” function was selected in the clinical menu, to set-up the therapy. Standard settings were established to adapt the patients during the first trial: - Mode: IN/EX - Inspiratory target: Off - Expiratory target: 5 cm/H2O - Pulse EX: On - T Adapt: On - Pause: 0 - Starting flow-dependent resistor on the expiratory line: diameter 6 mm Subjects were instructed to blow into the mouthpiece reaching the expiratory target on the display and activating the counter flow from the device (1cm/H2O) for a while. When learnt how to interact with the equipment, the patient was invited to maintain the expiratory target as long as possible. Meanwhile physiotherapist scaled down the resistors size until the patient was able to sustain the expiratory flow (EX) for at least 4 seconds, with the least possible effort, for 3 consecutives breaths. When the patient was comfortable with the expiratory phase, the same procedure was repeated to set the inspiratory resistance, starting from an inspiratory target of almost -2 cm/H2O. Patients were asked to inhale as slowly as possible while reaching and maintaining the target reported on the display, while physiotherapist adjusted the resistance to reach a sustained inspiratory flow (IN) for at least 2 seconds, with the least possible effort, for 3 consecutive breaths. When familiar with the inspiratory and expiratory exercises, patient was asked to hold his/her breathe, following the count-down (initial set at 3 seconds) appearing on the screen at the end of inspiration. Pause was optional in the first sessions and included only when patients were able to sustain the complete cycle (IN-PAUSE-EX) without exhaustion. SpO2, Respiratory Rate, Hearth Rate, dyspnoea and other symptoms were monitored at starting and ending each physiotherapy session. The patients were trained on how to manage the exercise and the device at home (assembling and clean the circuit, dealing with the user interface). Breathing Exercise Program The protocol included three daily session of 15 minutes for 15 consecutive days. Every session consisted of a number of consecutive IN-EX cycles (with or without tele-inspiratory pause) performed in sitting or alternating lateral positions. The main goal of every cycle was to reach the IN/EX targets as long as possible, ideally by increasing the time breath by breath. The total number of cycles per session could vary depending from the patient’s tolerance. Subjects were suggested to break the exercise for 1-2 minutes whenever they needed to, or when unable to maintain the performance (i.e., fail to reach the target or a fall in the IN or EX mean time). In table are described starting parameters for all patients. No other interventions were suggested during the observation period: patients were free to do their daily activities as usual. Data Collection Data were collected at baseline, before the first trial (T0) and at day 15th (T1). Dyspnea, Cough, Expectoration, Healthy status assessment and quality of life were evaluated with Breathlessness, Cough, and Sputum Scale (BCSS)(12-14), daily life activity and healthy status assessment with COPD Assessment Test (CAT)(13,14). BCSS is a three-item questionnaire rating breath, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms) (13). The CAT is a questionnaire designed to measure the impact of obstructive pulmonary disease on patient's health. It ranges from 0-40, where <10 is low impact, 10-20 medium, 21-30 high and > 30 very high (15,16). Pulmonary function testing (PFT) included: forced vital capacity (FVC), forced expiratory volume 1 second (FEV1), FEV1/FVC%, diffusing lung capacity monoxide (DLCO), maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), peak cough expiratory flow (PCEF). PFT was performed with a computerized body spirometer (VMAX 20 PFT Sensor Medics, Yorba Linda, CA, USA), according to the ATS/ERS Guidelines(17-19). Inspiratory muscle strength was assessed by measuring the MIP at RV. Expiratory muscle strength was assessed by measuring the MEP at TLC. The value obtained from the best of at least three efforts was used. All the measurements were obtained in upright position(20,21). Functional exercise capacity was recorded from the 6-minute walk test (6MWT) according to the American Thoracic Society Guidelines (22). The patients were guided to walk back and forth in a 30 m corridor. Modified Borg dyspnea score, respiratory and heart rate were recorded along with the total walking distance at the end of 6 min. At least two tests were performed and the best was recorded (22-25).Adherence to the exercise program was recorded into the device internal memory. We screened 140 patients with post COVID syndrome : among them 20 patients fulfilled inclusion criteria ( see study flow -fig 2) and was included in the study Primary and secondary outcomes The primary outcomes were changes in symptoms scores and CAT. Secondary outcomes were changes in respiratory function parameters, exercise capacity, respiratory muscles strength (MIP, MEP and SNIP ) and cough efficacy (PCEF) Statistical analysis Statistical analysis was performed with GraphPad Prism version 8.4 for macOS (GraphPad Software, La Jolla California USA, www.graphpad.com). Data are expressed as mean ± standard deviation (SD) or percentage . Data distribution was evaluated with the Shapiro-Wilk test. Pre-post treatment differences were evaluated by the t-test for Gaussian data and the Wilcoxon matched-pairs signed rank test for non-Gaussian data. P-values <0.05 were considered statistically significant. Considering that this was an observational pilot feasibility study and due to a lack of data a statistical power analysis was not performed. However, choosing a maximum level of significance equal to 0.05 allowed to ensure a high level of protection from the possibility of a type I error. 

研究设计：

单臂 

Study design：

Single arm 

纳入标准：

1. Aged >=18 years 2. Discharged from hospital after a COVID19 pneumonia 3. In spontaneous breathing 4. Able to breathe keeping a mouthpiece 5. Mild to moderate obstructive syndrome at spirometry (12) and at least one symptom among: (1) Breathlessness or feeling as “I can't take a deep breath” or inability to yawn (2) Cough (3) Chest pain/Chest tightness (4) Dyspnoea (at rest or during normal ADL) (5) Oxygen desaturation >=4% during daily physical activities 

Inclusion criteria

1. Aged >=18 years 2. Discharged from hospital after a COVID19 pneumonia 3. In spontaneous breathing 4. Able to breathe keeping a mouthpiece 5. Mild to moderate obstructive syndrome at spirometry (12) and at least one symptom among: (1) Breathlessness or feeling as I can't take a deep breath or inability to yawn (2) Cough (3) Chest pain/Chest tightness (4) Dyspnoea (at rest or during normal ADL) (5) Oxygen desaturation >=4% during daily physical activities 

排除标准：

Already on treatment with NIV or CPAP before COVID 19 - Oxygen supplementation at rest - Inability or refusal to collaborate - Lack of informed consent - Severe obstructive syndrome ( forced expiratory volume 1 second - FEV1 - < 50% ) 

Exclusion criteria：

- Already on treatment with NIV or CPAP before COVID 19 - Oxygen supplementation at rest - Inability or refusal to collaborate - Lack of informed consent - Severe obstructive syndrome ( forced expiratory volume 1 second - FEV1 - < 50% ) 

研究实施时间：

Study execute time：

从From2021-01-18至To 2021-07-01 

征募观察对象时间：

Recruiting time：

从From2020-08-01至To 2021-01-16 

干预措施：

Interventions：

组别：

post covid 19

样本量：

 20

Group：

post covid 19

Sample size：

干预措施：

T-PEP 4

干预措施代码：

Intervention：

T-PEP 4

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Italy 

省(直辖市)：

 Genoa 

市(区县)：

 sestri levante 

Country：

 Italy 

Province：

 Genoa 

City：

 sestri levante 

单位(医院)：

 respiratory diseases unit 

单位级别：

 community hospital 

Institution
hospital：

 respiratory diseases unit  

Level of the institution：

 community hospital 

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标 

Outcome：

The primary outcomes were changes in symptoms scores and CAT.

Type：

Primary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标 

Outcome：

Secondary outcomes were changes in respiratory function parameters, exercise capacity, respiratory muscles strength (MIP, MEP and SNIP ) and cough efficacy (PCEF)

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

not applicable

Tissue：

人体标本去向

 使用后销毁 

说明

Fate of sample：

 Destruction after use 

Note：

征募研究对象情况：

Recruiting status：

结束

Completed

年龄范围：

Participant age：

最小 Min age 18 岁 years
最大 Max age 90 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

na

Randomization Procedure (please state who generates the random number sequence and by what method)：

not applicable

盲法：

Blinding：

not applicable

试验完成后的统计结果（上传文件）：

点击下载

Calculated Results ater
the Study Completed(upload file)：

download

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

internal database avalable after request

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

internal database avalable after request

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

electronic data via windows system

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

electronic data via windows system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

 2021-07-18
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