Clinical trial NCT05033730: Comparison Between VCV and FCV Through Ultra-thin Tube in Upper Airway Surgery
Official title: Comparative Study Between VolumeControlled Ventilation and FlowControlled Ventilation Through Ultra-thin Tube in Upper Airway Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilation Therapy; Complications
Trachea
Keywords: Flow Controlled Ventilation,
Tritube,
Volume Controlled Ventilation,
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Ventilation through the small endotracheal tube is not an uncommon situation. The indications for it differ from elective upper airway surgery to emergency ventilation through needle cricothyrotomy. Conventionally, ventilation through small endotracheal tubes has been challenging by jet ventilation with subsequent risk of barotrauma and inadequate gas exchange. Expiration during jet ventilation occurs passively.

Detailed description: Upper airway endoscopy (micro laryngoscopy (MLS), pan endoscopy) is a minor upper airway procedure needing short duration general anesthesia, small calibrate endotracheal tube and manipulation of the airway. Because of airway manipulation and the surgery involves the airway, which is being shared with the anesthesiologist, there is a risk of interruption of ventilation, oxygenation and loss of airway in addition to inherent complications of surgery.

Methods:

After the patients will receive information about the study and informed consent will be taken. The patients will be randomized. In the control group, (group A) ventilation will be performed according to the routine big endotracheal tube. In the treatment group (group B), the ultra-thin ventilation tube will be placed using laryngoscopy. All other treatment will be unchanged. Data collection will be started 5 min after the initiation of the study. Demographic data, Past medical history, and examinations data will be collected after acceptance of the patient to be enrolled into the study and other ventilation parameters will be collected 5 min after the start of the the study which is Skin incision Primary endpoint is; to evaluate whether the Flow Controlled Ventilation (FCV) can also achieve adequate oxygenation and ventilation through small tube or not.

Eligibility criteria: Inclusion Criteria:

* Adult population of both sex (ASA I, II).
* Between18-65 years of age.
* Patients for the upper airway.
* Patients need intubation/invasive mechanical ventilation.

Exclusion Criteria:

* ASA \>II
* Advanced Respiratory disease.
* Advanced cardiovascular disease.
* Smokers.
* Pregnancy.
* Recent upper airway trauma.
* Age less than 18 years or more than 65 years.
* Patients BMI of more than 35
* Refuse to sign the consent.

Primary outcomes:
measure: Measurement of dynamic chest wall compliance (mL/mbar)
timeFrame: During study time intra-operatively
measure: Airway Resistance (mbar*s/L)
timeFrame: During procedure time and intra-operatively
Secondary outcomes:
measure: Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)
timeFrame: Intra-operatively during procedure time
measure: Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.
timeFrame: During surgical procedure intra-operatively
measure: Postoperative sore throat according the Visual Analogue Scale (VAS)
timeFrame: After surgical procedure (2 and 24) hours.
measure: Kink of the small size tube (Tritube) (Yes/No)
timeFrame: During surgical procedure
measure: Surgeon satisfaction instance scale (1-5)
timeFrame: During surgical procedure
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: ACC&HGH, Hamad Medical Corporation
state: Doah
Study officials:
affiliation: Hamad Medical Corporation - HMC
name: Nabil Shallik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt J, Gunther F, Weber J, Wirth S, Brandes I, Barnes T, Zarbock A, Schumann S, Enk D. Flow-controlled ventilation during ear, nose and throat surgery: A prospective observational study. Eur J Anaesthesiol. 2019 May;36(5):327-334. doi: 10.1097/EJA.0000000000000967.
citation: Putz L, Mayne A, Dincq AS. Jet Ventilation during Rigid Bronchoscopy in Adults: A Focused Review. Biomed Res Int. 2016;2016:4234861. doi: 10.1155/2016/4234861. Epub 2016 Oct 26.
citation: Jeyarajah K, Ahmad I. Awake tracheal placement of the Tritube under flexible bronchoscopic guidance. Anaesthesia Cases. 2018 Jul;6(2):1-5.