Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
Phase: NA
Conditions: Tracheostomy
Sponsor: Aarhus University Hospital

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Consequence of open versus closed tracheostomy 
immediately after decannulation. 
 
 
Department of Anesthesiology and Intensive Care 
& 
Department of Otorhinolaryngology, Head and Neck Surgery 
 
Aarhus University Hospital   
Palle Juul-Jensens Boulevard 99  
DK-8200 Aarhus N 
Denmark 
 

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Indholdsfortegnelse 
PROJECT STAFF ............................................................................................................................................................ 3 
INTRODUCTION ............................................................................................................................................................ 4 
HYPOTHESIS .................................................................................................................................................................. 5 
AIMS ................................................................................................................................................................................. 5 
METHOD .......................................................................................................................................................................... 5 
POPULATION ....................................................................................................................................................................................... 5 
INCLUSION CRITERIA .......................................................................................................................................................................... 5 
EXCLUSION CRITERIA: ....................................................................................................................................................................... 5 
RISKS, SIDE EFFECTS AND DISADVANTAGES ...................................................................................................... 7 
SPIROMETRY ................................................................................................................................................................. 8 
UPPER-AIRWAY ENDOSCOPY ............................................................................................................................................................ 8 
DATA COLLECTION FROM THE PATIENTS’ MEDICAL JOURNAL ................................................................................................... 9 
Information to trial participants ............................................................................................................................................ 9 
DATA STORAGE AND NOTIFICATION OF AUTHORITIES ............................................................................... 10 
ETHICS ........................................................................................................................................................................... 10 
INFORMATION TO PROJECT PARTICIPANTS .................................................................................................... 10 
EXCLUSION OF PARTICIPANTS FROM THE TRIAL / STOPPING OF THE TRIAL ..................................... 11 
PROCEDURES IF A PARTICIPANT LEAVES THE TRIAL .................................................................................................................. 11 
FINANCING AND RESPONSIBILITIES .................................................................................................................... 11 
TIME-FRAME ................................................................................................................................................................ 12 
PUBLICATION .............................................................................................................................................................. 12 
REFERENCES ................................................................................................................................................................ 13 
 
 
 
 

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Project staff 
Louise Devantier  
MD 
Department of Otorhinolaryngology, Head and Neck Surgery 
Aarhus University Hospital  
Palle Juul-Jensens Boulevard 99  
DK-8200 Aarhus N 
Denmark 
E-mail: louise.devantier@aarhus.rm.dk 
 
Reinhold Helbo Jensen 
MD, consultant 
Intensive Care Unit 
Aarhus University Hospital 
Palle Juul-Jensens Boulevard 99 
DK-8200 Aarhus N 
Denmark 
E-mail: renihold.jensen@skejby.rm.dk 
 
Michael Pedersen 
Professor 
Department of Comparative Medicine Lab 
Aarhus University 
Palle Juul-Jensens Boulevard 99 
DK- 8200 Aarhus N 
Denmark 
michael@clin.au.dk 
 
Karen Juelsgaard Christiansen 
Nurse 
Department of Comparative Medicine Lab 
Aarhus University 
Palle Juul-Jensens Boulevard 99 
DK-8200 Aarhus N 
Denmark 
karen@clin.au.dk 
 
Thomas Pasgaard 
MD 
Department of anesthesiology and Intensive Care  
Aarhus University Hospital 
Palle Juul-Jensens Boulevard 99 
DK-8200 Aarhus N 
Denmark 
thompasg@rm.dk 
 
 
 

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Introduction 
The larynx organ (voice box) is located in the upper airway. The larynx houses the vocal folds 
and regulates airflow, which is essential for phonation, expiratory airway pressures and cough 
efficacy. A tracheostomy is an artificial opening of the airway, which is performed in the 
tracheal frontal wall below the larynx organ. The tracheostoma is afterwards kept open by a 
tracheostomy tube for prolonged mechanical ventilation or for the purpose of bypassing an 
obstruction of the upper airway, e.g. a tumor or inflammatory swelling.  
When the tracheostomy is no longer needed, the 
tracheostomy tube is removed; this procedure is 
known as decannulation. After decannulation the 
trachostoma will be covered by an external 
bandage, and the wound will be left to close 
spontaneously (Figure 1). Airflow will continue 
to bypass the larynx until the tracheostoma is 
closed to a level of airtightness. In the meantime, 
to enable speech and cough function, patients 
are instructed to apply pressure on the bandage 
with their fingers (Figure 2). The tracheostoma 
usually closes within a few days to weeks. 
However, surgical closure may become 
necessary [1]. The surgical approach is complex 
with a risk of developing subcutaneous 
emphysema [2]. Decannulation is an important 
step in the patient’s rehabilitation, especially 
after prolonged mechanical ventilation [3]. 
 
 
Figure 1: Open tracheostomy after decannulation. 
Figure 2: Neck bandage after decannulation. 

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Hypothesis 
- 
It is possible to restore/increase airflow in the upper airway with a temporary silicone 
closure disc immediately after decannulation.   
- 
Cough strength and speech function is significantly improved with the temporary 
silicone closure disc 
Aims 
We aim to measure expiration of airflow through mouth and evaluate cough strength and 
speech on patients with an open versus closed tracheostoma. Closure of the tracheostoma is 
achieved  by insertion of a temporary seal immediately after decannulation. 
Method 
Population 
20 patients from Intensive Care Unit or the Department of Otorhinolaryngology, Head and Neck 
Surgery at Aarhus University Hospital subjected to tracheostomy decannulation will be 
included. 
Inclusion criteria  
• Tracheostomy for minimum 7 days.  
• Age > 18 years. 
• Capped uncuffed tube size 7 or 8 for at least 24 hours. 
 
Exclusion criteria:  
Cognitive dysfunction (patients who are not able to cooperate with investigation) 
 
Day 1.  
1. Patients receive oral and written information.  
 
Day 2.  
1. Informed consent is obtained. 
2. Decannulation will follow standard procedure described in the hospital guideline.  

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3. Patients will be asked to speak and cough. Spirometry will be performed.  
4. Insertion of temporary closure seal “type 1”. 
5. Patients will be asked to cough and speak. Spirometry will be performed again.  
 
There will be an option for 2 different degrees of softness: Type 1 “shore 50” and Type 2 “shore 
60” (Figure 3). 
Glottic abnormalities and insertion of the first 
seal will be evaluated by endoscopic 
visualization. The endoscopy will be removed 
before spirometry test with the seal in place. In 
case of audible signs of insufficient sealing 
(weak voice and sound from the 
tracheostoma) seal type 2 will be tested. The 
rod will be anchored by 2 separate medical 
clamps outside the neck. See figure 4 and 5. 
Furthermore, a handheld newton meter will be 
attached to ensure and measure a constant 
force on the seal. 
 
 
 
 
 
 
 
Figure 3: Tracheostomy closed by silicone disc. 
Figure 4: Photo of sealing disc with safety thread. 
Figure 5: Sealing device with 2 safety clamps. 

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Number of Patients 
To our knowledge, no other study has  investigated the consequence of air leakage from a 
tracheostoma. Therefore, our sample size is based on few other studies on airway physiology 
related to tracheostomy decannulation. A study from 2002 investigated physiological effects of 
decannulation in tracheostomized patients with a taped dressing outside the neck; 9 patients were 
included in that study [4]. Two studies in peak cough flow parametres included 16 and 26 
patients, respectively [5, 6]. With reference to these 3 studies, we have chosen to apply for 
inclusion of 20 patients. When we have conducted tests in 10 patients, we wish to perform an 
interim analysis to evaluate the significance of differences in airway physiology with open 
tracheostoma versus closed tracheostoma.  
Risks, side effects and disadvantages  
The procedure will take place at the specialized treatment room in the Intensive Care Unit, 
Aarhus University Hospital, where all safety equipment for airway intervention is available and 
under supervision of specialists in anaestesiology will supervise.  Local anesthesia (xylocain 
spray) is applied through nose and into the tracheostoma, if the patient requests so. The seal 
will be sprayed with sterile saline water to minimize friction prior to insertion. Louise 
Devantier (MD, Department of Otorhinolaryngology, Head and Neck Surgery) and Thomas 
Pasgaard (MD, Department of Anaesthesiology and Intensive Care at Aarhus University 
Hospital) will perform the technical procedure in cooperation. Both physicians have thorough 
experience with tracheostomy. The patient may experience tickling cough during procedure. 
The insertion of the temporary closure seal is estimated to last 2 minutes. 
Risks for obstruction of the airway is mitigated by clamps and holding string. 
The seal and rod are made of medical grade silicone. A thread for safety precaution is attached 
to the seal. The thread will be anchored to a medical clamp before insertion. Total procedure is 
performed without removal of the clamp. In addition, the rod will be kept in place by a second 
clamp and manual hold during procedure. 
 
Additionally, design of the seal has taken the risk of airway obstruction into account. The seal 
dimension takes up max one third of the tracheal lumen. Average cross sectional area of the 
male adult trachea is approximately 2,8 cm2. The seal is 1 mm thick and a diameter of 26 mm. 

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With this dimension the seal will take up maximum 1/3 of the cross section area of the airway. 
The cross sectional area of a trachestomy tube size 7 and 8 is 0,865 cm2 - 1,11 cm2, respectively. 
While the material is flexible, the material and design ensures that the seal will stay in upright 
position despite some degree of tensioning from outside the neck. The device has been 
manufactured by Prolink Sourcing and Trading; a company experienced in manufacturing 
medical silicone devices. 
The seal and tube for insertion will be packed and sterilized locally at Aarhus University 
Hospital and the procedure will be performed according to standard clinical hygiene 
precautions and standard handling of tracheostomy. 
Spirometry 
Having the patient in a relaxed sitting position with both feet flat on the floor, the procedure 
consist of breathing through a mouthpiece with a nose clamp. Before performing the forced 
expiration, tidal (normal) breaths can be taken first, then a deep breath taken while still using 
the mouthpiece, followed by a further quick, full inspiration. Data collected by aspirometry. 1)  
Forced expiratory volume in 1 s (FEV1). 2)Forced vital capacity (FVC), the maximum amount of 
air that can be exhaled when blowing out as fast as possible. 3) Vital capacity (VC), the 
maximum amount of air that can be exhaled when blowing out as fast as possible. 4) FEV1/FVC 
ratio. 5) Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at 
a steady rate. 6) Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 
50% and 75% FVC are given. 7) Spirometry is generally a safe test. Some patients may feel a 
brief shortness of breath or dizziness after performance of the test. 
Upper-airway endoscopy 
Endoscopy (nasolaryngoscopy) uses a small flexible telescope. The scope is passed through the 
nose and into the throat. This is the most common method for examination of the voice box. 
The patient is awake during the procedure. Numbing medicine will be sprayed into nose and 
throat on request. This procedure typically takes less than 1 minute. 
Endoscopy visualization of the upper airway is standard procedure at decannulation in our Ear 
Nose and Throat department. 
 
Evaluation of cough and speech 

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In the newly decannulated patients, cough and speech is challenged (impaired) due to the 
artificial opening below the glottis. In order to evaluate cough strength, the cough strength 
scoring tool adopted from Duan et al [7] will be used . The scoring cough pattern ranges from 0 
– 5: 
• 0= no cough on command 
• 1= audible movement of air, but no audible cough 
• 2= weakly (barely) audible cough 
• 3= clearly audible cough 
• 4= stronger cough 
• 5= multible sequential strong coughs.  
 
A similar tool (Likert scale) will be used to evaluate speech function. 
 
Data collection from the patients’ medical journal 
In order to assess any unforeseen risks for the patients, we will assess the patient medical journal 
for an overall assessment of inclusion into the study. Furthermore, we will record age, sex, 
cannulation time, verification of tube capping time, tube size and tube product supplier, 
neurologic, height and weight. 
 
Information to trial participants  
 
Trial participant will orally and in writing receive detailed information of the study 
in which they will participate. Written information includes the "Information to trial Participant" 
and "Your Rights as a trial participant in a biomedical research trial" from the Central Scientific 
Ethical Committee. A doctor gives the detailed oral information. This is done in closed room and 
the presence of an observer will be optional. The doctor must ensure that the participant has 
read and understood the above-mentioned material before the participant signs the trial consent 
form. Patients will have at least 24 hours of time for reflection before decision. The participants 
are informed that the consent form may be withdrawn at any time without justification.  
 

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Data storage and notification of authorities   
All data will be stored and handled in accordance with the legislation on data storage and data 
security. The participant’s data are logged under a participant number, and a participant list is 
created where consistency between the participant number, participant name, and social 
security number is documented. The participant list and participant data are archived separately. 
Data and documents related to the study will be stored for 5 years after completion of the project.  
The project will be registered in Region Midt internal records of research projects.  Within 90 
days after the end of the study, the Research Ethics Committee will be notified. The above 
mentioned authorities will be informed within 15 days if the study for some reason ends sooner 
than planned. 
Ethics 
Before the inclusion of project participants the Region Midt Research Ethics Committee must 
approve the project. The act regarding handling of general data protection regulation and the 
data protection act will be respected. Participants will receive both written and oral information 
prior to study entry and it will be highlighted that participation is voluntary. 
If trial staff during the trial become aware of the health concerning information that is relevant 
to the participants, e.g. results from the test, it will not be possible for the participant to refuse 
this information, as we will not be able to vouch for the consequence of withholding such 
information. We will inform of this at the information interview, and the participant must agree 
to these terms to participate in the project. 
Potential benefit for the individual patient and future patients overweight the potential small 
risk for the participating patients. Participating patients will receive enhanced observation, 
caution and ventilation assess compared to those undergoing normal procedure. 
Information to project participants  
Potential project participants will orally and in writing receive detailed information of the study 
the day prior to decannulation. Written information includes the "Information to trial 
Participant" and "Your Rights as a trial participant in a biomedical research trial" from the 
Central Scientific Ethical Committee. A doctor gives the detailed oral information. This is done in 

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closed room and the presence of an observer will be optional. The doctor must ensure that the 
participant has read and understood the above-mentioned material before the participant signs 
the trial consent form. The participants are informed that a given consent may be withdrawn at 
any time without justification and without any consequences for the patient. 
Exclusion of participants from the trial / stopping of the trial 
Trials Participant may at any time during the study withdraw their consent form. A doctor will 
address unforeseen side effects or events. Trial participants that do not meet the inclusion 
criteria will not be included in the trial. 
Procedures if a participant leaves the trial  
If a trial participant for one reason or another leaves the study is completed a new volunteer will 
be recruited to replace the discontinued participant. This will be done by the same procedure as 
the other inclusions. There will be no further follow-up for discontinued participants. 
Financing and responsibilities  
Reinhold Helbo Jensen, consultant, is the main supervisor and initiator of the project. Louise 
Devantier and Karen Juelsgaard Christiansen are in charge of the daily management of the 
project. Reinhold Helbo Jensen and Thomas Pasggard will be in charge of the enrolment of 
participants. Louise Devantier, Thomas Pasgaard and Michael Pedersen will be in charge of data 
analyses and dissemination of the results. 
An Exploratory pre-seed grant from the Novo Nordisk Foundation has supported (350.000 
DKK) the production of a seal suitable for temporary closure test of a tracheostomy 
immediately after decanulation.  The Danish Medicine Agency has been contacted in order to 
clarify our obligation to notify the tracheostoma sealing disc, which is not a commercial 
product. The sealing disc has been developed for the purpose of the present study. Generation 
of data may be useful in a development of a new device for sealing a tracheostomy, however 
without direct economic benefit from our study. Karen Juelsgaard is beside her job as critical 
care nurse in ICU and project nurse at Comparative Medicine Lab engaged with the 
development of a new device for tracheostomy. 

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The patients will be covered by Aarhus University Hospital’s patient insurance fund in case of 
any unforeseen event or side effects originated from the study. 
Time-frame 
The main time frame of the project will be: 
• Inclusion of study participants is intended to begin in June 2019. 
• Data collection is expected to be completed no later than June 2022. 
Publication  
Any reference to or publication of the results from the study can only take place with mutual 
agreement of the project participants. Project participants will cooperate to have the results 
published with respect to the Vancouver criteria. Regardless if the results are negative, positive 
or inconclusive it will be published. We aim to publish in international journals preferably with 
open access. 
 
 
 

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References 
1. 
Medicine, J.H. Tracheostomy Service. 2019  21.05.2019]; Available from: 1.
 
https://www.hopkinsmedicine.org/tracheostomy/living/decannulation.html. 
2. 
Evertt, A.E., Closure of a chronic Tracheocutaneus fistula. 2017, Youtube. 
3. 
O'Connor, H.H. and A.C. White, Tracheostomy decannulation. Respir Care, 2010. 55(8): p. 
1076-81. 
4. 
Chadda, K., et al., Physiological effects of decannulation in tracheostomized patients. 
Intensive Care Med, 2002. 28(12): p. 1761-7. 
5. 
McKim, D.A., et al., Tracheostomy decannulation and cough peak flows in patients with 
neuromuscular weakness. Am J Phys Med Rehabil, 2012. 91(8): p. 666-70. 
6. 
Chang, A.B., The physiology of cough. Paediatr Respir Rev, 2006. 7(1): p. 2-8. 
7. 
Duan, J., et al., Semiquantitative cough strength score for predicting reintubation after 
planned extubation. Am J Crit Care, 2015. 24(6): p. e86-90.