Tracheal StenosisNCT06061380
Challenges and Management of Post-intubation Tracheal Stenosis
An observational study of Tracheal Stenosis, run by Wollo University at 1 site in Ethiopia.
Trial summary
Management of a "difficult airway" remains one of the most relevant and challenging tasks for anesthesiologists and pulmonary physicians. Tracheal stenosis is not common but serious complication of prolonged intubation and tracheostomy patients. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- no intervation taken
- How many people
- 1 participants
- Where
- 1 siteEthiopia
- Study dates
- 23 Jan 2021to 24 Jan 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A mother developing post-intubation tracheal stenosis
Who may be able to join
- Cases with tracheal stenosis caused by only prolonged intubation
- Female
Who cannot join
- Any tracheal stenosis caused by trauma, mass compression
- Being male
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Dessie comprehensive specilized hospital
Dessie, Amhara, 801103
About this study
Official title: Challenges and Management of Post-intubation Tracheal Stenosis: A Case Report and Literature Review
Management of a "difficult airway" remains one of the most relevant and challenging tasks for anesthesiologists and pulmonary physicians. Tracheal stenosis is not common but serious complication of prolonged intubation and tracheostomy patients. The incidence of stenosis is very low if intubation lasts less than a week and patients may be asymptomatic for a long time. On presentation, tracheal stenosis may be mistaken for asthma with dyspnea and stridor. The choice of treatment depends on the site, grade, and length of stenosis, as well as on patient comorbidities, history of previous interventions, and the expertise of the surgical team. In this case report the investigators wanted to present a case of a 25-year-old female with post-intubation tracheal stenosis who was intubated for the management of severe preeclampsia.
Read the detailed description
Trachea stenosis is a rare but life-threatening condition and is caused by congenital problems, post-intubation injury, trauma from surgery, tracheal tumor and compression of the trachea by tumor, or accidents, inhalation injuries or inflammatory diseases such as Wegener's granulomatosis, sarcoidosis, or systemic lupus erythematous. The investigator would like to report tracheal stenosis secondary to prolonged intubation
Case presentation
A 25-year-old female patient (height, 150 cm; weight, 50kg; body mass index, 20kg/m2) was referred to Minilik referral hospital from Debrebirhan referral hospital with a history of prolonged intubation (7 days), following severe eclampsia and uncontrolled seizure. She gives birth through spontaneous vaginal delivery in a local health care center and she doesn't know that she was preeclamptic before delivery and develops seizures after delivery so she was admitted to ICU to control her airway and stayed on a mechanical ventilator for 7 days. After extubation, she develops shortness of breath and difficulty talking. During the preoperative visit, the investigator found her on a face mask with a flow rate of 2 l/mint. She has difficulty in breathing and a dry cough associated with the stenosis but no fever or other symptoms of acute infection. Hypertension was controlled and no complications were associated with it. She had no family history of disease or any notable medical conditions. On physical examination, she has normal findings with stable vital signs of RR =21, PR =80, and BP =140/90. A three-dimensional CT scan of the neck shows trachea stenosis 14mm in length with 5mm in thickness of the wall at the level of the sternal notch. Chest CT scan also reveals tracheal stenosis at the thoracic inlet. Her complete blood profile, kidney function test, liver function test, clotting parameters, and electrocardiogram were within normal limits.
On the day of surgery, the patient was taken to the operation theatre while she was on face mask O2 and written informed consent was taken. Two wide-bore peripheral lines were secured and the patient was premeditated with dexamethasone 8mg in OT. Then the team transferred her to the OR quickly and applied the minimum standard monitoring (SpO2, non-invasive BP, ECG, and ETCO2 monitoring) in a sitting position while she was on nasal oxygen. 50 mg peptide was administered. Difficult airway was anticipated and a difficult airway cart was kept ready. Small size cuffed tubes up to 4mm ID were arranged. The patient was pre-oxygenated in a sitting position with 3 VC breathing and an induction dose of propofol (100mg) was given and halothane opened at 3% concentration. 2mg/kg of IV lidocaine was given and as anesthesia deepened laryngoscopy started. During direct laryngoscopy, the cord is visible posteriorly with a good view and intubation was tried with a cuffed tube 6.0 mm ID. The tube passed the glottis but unable to advance below it and immediately this tube changed to 5.0 mm but it was failed. Finally, a 4.0 mm ID tube was inserted by rotating side to side gently and the cuff was inflated to prevent any gas leakage, and the tube was secured at the 20 cm mark. There was significant resistance in the breathing bag so the patient was ventilated by decreasing tidal volume and increasing the rate for keeping Etco2 between 30- 35. Due to the manipulation and preexisting hypertension, BP was raised up to 200/115 so the investigator administered 5 mg hydralazine and 100mg hydrocortisone for the manipulation. Anaesthesia was maintained with Oxygen and Isoflurane with an injection of vecuronium intermittently. After securing the airway and proper positioning surgery was started. IV fluid was warmed and the required fluid amount was run in both hands. When the surgeon reached the stenosis part they inserted another sterile 6.0 mm tube below the stenosis. the surgeon's anastomosis of the remaining part.
Mid sternotomy was done and the stenosed segment was opened, a second cuffed ETT of 6.0 mm ID was passed through the distal tracheal segment (below the stenosis) by the surgeon. The circuit was disconnected from the first endotracheal tube and new sterile ventilator tubing was connected to the second endotracheal tube to continue ventilation. Bilateral air entry confirmed the tube was secured by suture applied by surgeons the cuff inflated to minimize the air leakage, and the patient was ventilated. After resection of the stenosis part, the oral 4.0mm tube was changed by a 6.0 mm tube. The cuff was inflated to prevent a gas leak. Bilateral equal chest movement was visualized. Surgery was kept continued and 1 unit of blood was given after the patient had her allowable blood loss. After completion of surgery and the appearance of adequate respiratory efforts, 1mg atropine and 2.5 mg neostigmine were given for reversal, and the patient was shifted to ICU with an endotracheal tube in situ on spontaneous respiration. The patient was extubated when she became awake with a respiratory rate of 20, HR=89, BP=128/84 adequate breathing.
H story summary History of present illness: shortness of breathing due to tracheal stenosis General condition: Awake, Alert, and Oriented, wt. 50, Ht. 150cm Medications: hydrocortisone 100mg IV BID Allergies: Not Known Drug Allergy Past Medical History: eclampsia Physical Exam: V/S: within the normal limit for age; BMI= 20 HEENT: pink conjunctive, tonsillar enlargement, otherwise normal Airway exam: TMJ: free/mobile Mallampati class II, stridor Pulmonary: Clear to auscultation and percussion, bilateral air entry with equal breath sound, no wheezing CVS: s1 \& s2 well heard + no murmur or gallop Investigation: Hgb./Hct.: 12.3/39 BG: O +ve, PT=12 seconds (5-14) INR: 1.2, Platelets: 283,000, ECG normal Assessment: ASA II + tracheal stenosis + preeclampsia + fit for anesthesia
- Conditions
- Tracheal Stenosis
- Being tested
- no intervation taken
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervation takenOther
What is being measured
The primary outcome is the main question the study is designed to answer.
post-intubation tracheal stenosis
The severity of tracheal stenosis was based on Cotton criteria confirmed by a Computerized tomography (CT) scan and the size of the tube that passed through it. If the Tracheal diameter is> 8 mm but symptomatic mild, 5-8 mm moderate, and <5 mm severe, and the effect of the severe tracheal stenosis was observed on anesthesia position, tracheal intubation technique, tube size that would challenge anesthesia management is reported
Measured: the patient was follwed for 1 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start23 Jan 2021
- Primary completion24 Jan 2021
- Study completion24 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynalem Befkadu Woldemichael, Wollo University
- Investigators
- Aynalem Bk Woldemichael, MSC, Principal investigator, Wollo Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061380
- Sponsor's protocol ID
- 458840
- Status last verified
- Sep 2023
- First submitted
- 14 May 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges and Management of Post-intubation Tracheal Stenosis: A Case Report and Literature Review
- ClinicalTrials.gov ID
- NCT06061380
- Acronym / sponsor ID
- 458840
- Conditions
- Tracheal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 24 Jan 2021 (actual)
- Study completion
- 24 Jan 2021 (actual)
- First posted
- 29 Sep 2023 (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.
Management of a "difficult airway" remains one of the most relevant and challenging tasks for anesthesiologists and pulmonary physicians. Tracheal stenosis is not common but serious complication of prolonged intubation and tracheostomy patients. The incidence of stenosis is very low if intubation lasts less than a week and patients may be asymptomatic for a long time. On presentation, tracheal stenosis may be mistaken for asthma with dyspnea and stridor. The choice of treatment depends on the site, grade, and length of stenosis, as well as on patient comorbidities, history of previous interventions, and the expertise of the surgical team. In this case report the investigators wanted to present a case of a 25-year-old female with post-intubation tracheal stenosis who was intubated for the management of severe preeclampsia.
Detailed description
Trachea stenosis is a rare but life-threatening condition and is caused by congenital problems, post-intubation injury, trauma from surgery, tracheal tumor and compression of the trachea by tumor, or accidents, inhalation injuries or inflammatory diseases such as Wegener's granulomatosis, sarcoidosis, or systemic lupus erythematous. The investigator would like to report tracheal stenosis secondary to prolonged intubation
Case presentation
A 25-year-old female patient (height, 150 cm; weight, 50kg; body mass index, 20kg/m2) was referred to Minilik referral hospital from Debrebirhan referral hospital with a history of prolonged intubation (7 days), following severe eclampsia and uncontrolled seizure. She gives birth through spontaneous vaginal delivery in a local health care center and she doesn't know that she was preeclamptic before delivery and develops seizures after delivery so she was admitted to ICU to control her airway and stayed on a mechanical ventilator for 7 days. After extubation, she develops shortness of breath and difficulty talking. During the preoperative visit, the investigator found her on a face mask with a flow rate of 2 l/mint. She has difficulty in breathing and a dry cough associated with the stenosis but no fever or other symptoms of acute infection. Hypertension was controlled and no complications were associated with it. She had no family history of disease or any notable medical conditions. On physical examination, she has normal findings with stable vital signs of RR =21, PR =80, and BP =140/90. A three-dimensional CT scan of the neck shows trachea stenosis 14mm in length with 5mm in thickness of the wall at the level of the sternal notch. Chest CT scan also reveals tracheal stenosis at the thoracic inlet. Her complete blood profile, kidney function test, liver function test, clotting parameters, and electrocardiogram were within normal limits.
On the day of surgery, the patient was taken to the operation theatre while she was on face mask O2 and written informed consent was taken. Two wide-bore peripheral lines were secured and the patient was premeditated with dexamethasone 8mg in OT. Then the team transferred her to the OR quickly and applied the minimum standard monitoring (SpO2, non-invasive BP, ECG, and ETCO2 monitoring) in a sitting position while she was on nasal oxygen. 50 mg peptide was administered. Difficult airway was anticipated and a difficult airway cart was kept ready. Small size cuffed tubes up to 4mm ID were arranged. The patient was pre-oxygenated in a sitting position with 3 VC breathing and an induction dose of propofol (100mg) was given and halothane opened at 3% concentration. 2mg/kg of IV lidocaine was given and as anesthesia deepened laryngoscopy started. During direct laryngoscopy, the cord is visible posteriorly with a good view and intubation was tried with a cuffed tube 6.0 mm ID. The tube passed the glottis but unable to advance below it and immediately this tube changed to 5.0 mm but it was failed. Finally, a 4.0 mm ID tube was inserted by rotating side to side gently and the cuff was inflated to prevent any gas leakage, and the tube was secured at the 20 cm mark. There was significant resistance in the breathing bag so the patient was ventilated by decreasing tidal volume and increasing the rate for keeping Etco2 between 30- 35. Due to the manipulation and preexisting hypertension, BP was raised up to 200/115 so the investigator administered 5 mg hydralazine and 100mg hydrocortisone for the manipulation. Anaesthesia was maintained with Oxygen and Isoflurane with an injection of vecuronium intermittently. After securing the airway and proper positioning surgery was started. IV fluid was warmed and the required fluid amount was run in both hands. When the surgeon reached the stenosis part they inserted another sterile 6.0 mm tube below the stenosis. the surgeon's anastomosis of the remaining part.
Mid sternotomy was done and the stenosed segment was opened, a second cuffed ETT of 6.0 mm ID was passed through the distal tracheal segment (below the stenosis) by the surgeon. The circuit was disconnected from the first endotracheal tube and new sterile ventilator tubing was connected to the second endotracheal tube to continue ventilation. Bilateral air entry confirmed the tube was secured by suture applied by surgeons the cuff inflated to minimize the air leakage, and the patient was ventilated. After resection of the stenosis part, the oral 4.0mm tube was changed by a 6.0 mm tube. The cuff was inflated to prevent a gas leak. Bilateral equal chest movement was visualized. Surgery was kept continued and 1 unit of blood was given after the patient had her allowable blood loss. After completion of surgery and the appearance of adequate respiratory efforts, 1mg atropine and 2.5 mg neostigmine were given for reversal, and the patient was shifted to ICU with an endotracheal tube in situ on spontaneous respiration. The patient was extubated when she became awake with a respiratory rate of 20, HR=89, BP=128/84 adequate breathing.
H story summary History of present illness: shortness of breathing due to tracheal stenosis General condition: Awake, Alert, and Oriented, wt. 50, Ht. 150cm Medications: hydrocortisone 100mg IV BID Allergies: Not Known Drug Allergy Past Medical History: eclampsia Physical Exam: V/S: within the normal limit for age; BMI= 20 HEENT: pink conjunctive, tonsillar enlargement, otherwise normal Airway exam: TMJ: free/mobile Mallampati class II, stridor Pulmonary: Clear to auscultation and percussion, bilateral air entry with equal breath sound, no wheezing CVS: s1 \& s2 well heard + no murmur or gallop Investigation: Hgb./Hct.: 12.3/39 BG: O +ve, PT=12 seconds (5-14) INR: 1.2, Platelets: 283,000, ECG normal Assessment: ASA II + tracheal stenosis + preeclampsia + fit for anesthesia
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A mother developing post-intubation tracheal stenosis
Key inclusion criteria (2 listed)
- Cases with tracheal stenosis caused by only prolonged intubation
- Female
Key exclusion criteria (2 listed)
- Any tracheal stenosis caused by trauma, mass compression
- Being male
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 |
|---|---|---|
| no intervation taken | Other | – |
Primary outcome
post-intubation tracheal stenosis
Time frame: the patient was follwed for 1 wk
The severity of tracheal stenosis was based on Cotton criteria confirmed by a Computerized tomography (CT) scan and the size of the tube that passed through it. If the Tracheal diameter is> 8 mm but symptomatic mild, 5-8 mm moderate, and <5 mm severe, and the effect of the severe tracheal stenosis was observed on anesthesia position, tracheal intubation technique, tube size that would challenge anesthesia management is reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Aynalem Bk Woldemichael, MSC principal investigator
Wollo Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis, run by Wollo University at 1 site in Ethiopia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-intubation tracheal stenosis (time frame: the patient was follwed for 1 wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.