Factors affecting successful tracheostomy removal: a prospective observational study
| ISRCTN | ISRCTN16452082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16452082 |
| Secondary identifying numbers | CMRPG5K0101 |
- Submission date
- 22/08/2024
- Registration date
- 23/08/2024
- Last edited
- 23/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
A tracheostomy is an opening that is surgically created through the neck into the windpipe to allow air to fill the lungs. This study is looking into the best ways to decide when it's safe to remove a tracheostomy tube. The researchers want to understand which factors can help doctors determine the right time for this important step in a patient’s recovery.
Who can participate?
Patients aged 18 to 80 years who have a tracheostomy and meet certain medical criteria. They should be stable enough to go through some breathing tests and be able to follow simple instructions from their doctors.
What does the study involve?
Participants will undergo a series of breathing tests to measure their lung function. Based on these results, doctors will decide when to try removing the tracheostomy tube. They will also follow up with participants for 60 days to see how they do after the tube is removed.
What are the possible benefits and risks of participating?
Participating may help the researchers find better ways to determine when it's safe to remove a tracheostomy tube, which could benefit future patients. However, as with any medical procedure, there are risks, such as potential breathing difficulties after the tube is removed.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
February 2020 to February 2024
Who is funding the study?
Chang Gung Medical Foundation (Taiwan)
Who Is the main contact?
Mrs Mei-Hsiu Chuang, s22006@cgmh.org.tw
Contact information
Public, Scientific, Principal Investigator
No.123, Dinghu Road
Gueishan Dist.
Taoyuan
33378
Taiwan
| Phone | +886 (0)965237785 |
|---|---|
| s22006@cgmh.org.tw |
Study information
| Study design | Single-center diagnostic observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Predictors of removing tracheostomy in 60 days during the COVID pandemic era: a prospective observational study |
| Study hypothesis | Parameters of pulmonary function tests could be used to predict the successful removal of tracheostomy. |
| Ethics approval(s) |
Approved 20/02/2020, Chang Gung Medical Foundation Institutional Review Board (199, Tung Hwa North Road, Taipei, 10507, Taiwan; +886 (0)3 3196200; s22006@cgmh.org.tw), ref: 202000095B0 |
| Condition | Tracheostomy removal |
| Intervention | This prospective observational study was conducted to identify optimal indicators for tracheostomy tube removal during the COVID-19 pandemic. The study collected data from patients admitted to Chang Gung Memorial Hospital in Taoyuan between 01/03/2020 and 31/12/2023. The hospital focuses on subacute and chronic care. Patients were evaluated for their suitability for tracheostomy tube removal by pulmonologists or otolaryngologists based on specific criteria, including consciousness level and the ability to cooperate with respiratory tests. Patients with unstable vital signs, those who were pregnant or breastfeeding, or those who could not cooperate with testing were excluded from the study. Once patients were deemed eligible for decannulation, respiratory therapists conducted tests to collect relevant pulmonary function parameters. Tracheostomy tube removal was performed within 48-96 hours after these tests. The study then observed whether patients could maintain stable respiratory conditions without needing tube reinsertion within 60 days. Outcome Assessment The primary outcome of the study was to identify factors that predict successful tracheostomy tube removal within 60 days. Success was defined as the removal of the tracheostomy tube within 3 days without the need for reinsertion within the 60-day observation period. The study's longer observation period compared to other studies aimed to provide a more comprehensive understanding of long-term outcomes. Success rates from previous studies vary, with definitions ranging from decannulation without complications for at least two weeks to not requiring reinsertion for over 72 hours after tube removal. Covariates The study collected demographic data including age, gender, smoking habits, and underlying medical conditions such as diabetes, hypertension, heart failure, COVID-19 infection, chronic obstructive pulmonary disease (COPD), pneumonia, and others. Additionally, biochemical profiles and body mass index (BMI) were recorded before the respiratory tests. Pulmonary function-related covariates included the interval between tracheostomy insertion and testing, presence of airway polyps, excessive airway secretions, cough strength, use of a nasogastric tube, and various respiratory parameters such as maximum inspiratory and expiratory pressures, rapid shallow breathing index (RSBI), minute ventilation, tidal volume, respiratory rate, heart rate, oxygen saturation, peak expiratory flow rate (PEFR), and forced vital capacity (FVC). These parameters were measured within 2-4 days before decannulation, with the highest value of three tests being recorded to minimize errors. Statistical Analysis The study employed various statistical methods to analyze patient characteristics and differences in respiratory function tests. Categorical variables were analyzed using chi-square or Fisher's exact test, while continuous variables were analyzed using independent t-tests. Logistic regression was used to assess the impact of various covariates on the likelihood of successful decannulation. Pearson correlation and correlation matrix were utilized to evaluate relationships between covariates. Candidate predictors for successful decannulation within 60 days were identified using C-statistics with a 95% confidence interval. The optimal threshold for these predictors was determined using Youden's J statistic based on the receiver operating characteristic (ROC) curve. The area under the ROC curve (AUROC) was then used to identify the models with the highest predicted probability of successful decannulation. Statistical analyses were performed using IBM SPSS Statistics, with a p-value of less than 0.05 considered statistically significant. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Tracheostomy is removed successfully within 2-4 days after pulmonary test and tracheostomy is not re-inserted for 60 days, measured by observation |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/02/2020 |
| Overall study end date | 24/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 46 |
| Participant inclusion criteria | 1. Patients available for tracheostomy tube removal 2. Consciousness levels meeting a Glasgow Coma Scale of E4VTM6 3. Able to follow instructions from respiratory therapists for testing |
| Participant exclusion criteria | 1. Pregnant or breastfeeding patients 2. Patients with inability to cooperate with testing 3. Patients with unstable vital signs 4. Patients transferred to another hospital |
| Recruitment start date | 01/03/2020 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Gueishan Dist.
Taoyuan
33378
Taiwan
Sponsor information
Hospital/treatment centre
No.5, Fuxing Street
Guishan Dist.
Taoyuan
33342
Taiwan
| Phone | +886 (0)3 3196200 |
|---|---|
| a0643@cgmh.org.tw |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analyzed in this study would be available upon adequate request from Mei-Hsiu Chuang (s22006@cgmh.org.tw) |
Editorial Notes
23/08/2024: Study's existence confirmed by the Chang Gung Medical Foundation Institutional Review Board.
