Comparison Between VCV and FCV Through Ultra-thin Tube in Upper Airway Surgery

Ventilation Therapy; Complications Clinical Trial

Official title:

Comparative Study Between VolumeControlled Ventilation and FlowControlled Ventilation Through Ultra-thin Tube in Upper Airway Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033730
• Other study ID #: MRC-01-20-164
• Secondary ID: MRC-01-20-164
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• Source: Hamad Medical Corporation
• Contact: Nabil A. Shallik, M.D.
• Phone: +97455439264
• Email: nshallik[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trachea
• Tracheal Diseases
• Ventilation Therapy; Complications

Intervention

Device:
• Flow Controlled Ventilation
Mechanically ventilated using Flow Controlled Ventilation (FCV)

Locations

Country	Name	City	State
Qatar	ACC&HGH, Hamad Medical Corporation	Doha	Doah

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (3)

Jeyarajah K, Ahmad I. Awake tracheal placement of the Tritube under flexible bronchoscopic guidance. Anaesthesia Cases. 2018 Jul;6(2):1-5.

Putz L, Mayné A, Dincq AS. Jet Ventilation during Rigid Bronchoscopy in Adults: A Focused Review. Biomed Res Int. 2016;2016:4234861. Epub 2016 Oct 26. Review. — View Citation

Schmidt J, Günther 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of dynamic chest wall compliance (mL/mbar)	Dynamic chest wall compliance changes due to Flow Controlled Ventilation (FCV) in comparison to routine Volume Controlled Ventilation(VCV)	During study time intra-operatively
Primary	Airway Resistance (mbar*s/L)	This measures the airway resistance changes due to Flow Controlled Ventilation (FCV) in comparison to the traditional Volume Controlled Ventilation(VCV)	During procedure time and intra-operatively
Secondary	Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)	This will measure the patient oxygenation during intervention in both studied groups and using the arterial blood gases	Intra-operatively during procedure time
Secondary	Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.	This measures the patient ventilation during intervention in both studied groups using capnogram and arterial blood gases	During surgical procedure intra-operatively
Secondary	Postoperative sore throat according the Visual Analogue Scale (VAS)	Postoperative sore throat after 2 and 24 hours using the VAS score (0-10). (Zero=no pain and 10 = for the most sever pain.	After surgical procedure (2 and 24) hours.
Secondary	Kink of the small size tube (Tritube) (Yes/No)	Kink of the small (Tritube) (using machine alarms for obstruction and visual inspection) so will be (yes) for partial or complete obstruction and (no) for the absence of obstruction)	During surgical procedure
Secondary	Surgeon satisfaction instance scale (1-5)	the Surgeon satisfaction score according the space free for the surgery which range from (1= poor, 2= medium, 3= good, 4= very good, and 5= excellent).	During surgical procedure