Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06061380 |
| Other study ID # |
458840 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 23, 2021 |
| Est. completion date |
January 24, 2021 |
Study information
| Verified date |
September 2023 |
| Source |
Wollo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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
