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CompletedNCT06061380Updated Sep 29, 2023

Challenges and Management of Post-intubation Tracheal Stenosis

An observational study in Tracheal Stenosis, sponsored by Wollo University. Completed at 1 site in Ethiopia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Wollo University · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
1
Sex
Female
01

Study 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. 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

02

Conditions studied

  • Tracheal Stenosis
03

In context

Tracheal Stenosis

37 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.

This study's enrollment of 1 is below the median of 78 across 12 observational studies indexed under Tracheal Stenosis.

Browse Tracheal Stenosis studies →

Lead sponsor

Wollo University is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A mother developing post-intubation tracheal stenosis

Inclusion criteria

  • Cases with tracheal stenosis caused by only prolonged intubation
  • Female

Exclusion criteria

Exclusion Criteria:

  • Any tracheal stenosis caused by trauma, mass compression
  • Being male
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
1 participant (actual)
Target follow-up
7 Days
Patient registry
Yes

Interventions

  • Otherno intervation taken
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: the patient was follwed for 1 wk

07

Study locations

1 site
  • Dessie comprehensive specilized hospital
    Dessie, Amhara 801103, Ethiopia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06061380
Lead sponsor
Wollo University
Responsible party
Aynalem Befkadu Woldemichael (Principal Investigator, Wollo University) — Principal investigator
First posted
Sep 29, 2023
Start date
Jan 23, 2021
Primary completion
Jan 24, 2021
Completion
Jan 24, 2021
Last update
Sep 29, 2023

Study contacts

Aynalem Bk Woldemichael, MSC
principal investigator · Wollo Universty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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