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

Not Applicable

• Conditions: Trachea; Ventilation Therapy; Complications
• Interventions: Device: Flow Controlled Ventilation

• Registration Number: NCT05033730
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study Start: 2020-10-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-30
• Last Update Submitted: 2021-08-30
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention Group: (Group B)	Flow Controlled Ventilation	General Anesthesia will be induced with IV Induction of Anesthesia by an anesthesiologist with Propofol (Target controlled infusion), Remifentanil (Target controlled infusion), and Rocuronium (0.5mg/Kg) for muscle relaxation. The airway will be secured with cuffed Tritube after direct laryngoscopy. They will be mechanically ventilated using Flow Controlled Ventilation (FCV) with 40% Oxygen, Flow rate:13L/Min., Peak Airway Pressure (15 cmH2O), and a PEEP of (5 cmH2O) to keep ETCO2 of 40 mmHg or less. The anesthesia will be maintained with Intravenous Infusion of Propofol, Remifentanil (TCI) to keep BIS 40-60.

Primary Outcome Measures

Name	Time	Method
Measurement of dynamic chest wall compliance (mL/mbar)	During study time intra-operatively	Dynamic chest wall compliance changes due to Flow Controlled Ventilation (FCV) in comparison to routine Volume Controlled Ventilation(VCV)
Airway Resistance (mbar*s/L)	During procedure time and intra-operatively	This measures the airway resistance changes due to Flow Controlled Ventilation (FCV) in comparison to the traditional Volume Controlled Ventilation(VCV)

Secondary Outcome Measures

Name	Time	Method
Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)	Intra-operatively during procedure time	This will measure the patient oxygenation during intervention in both studied groups and using the arterial blood gases
Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.	During surgical procedure intra-operatively	This measures the patient ventilation during intervention in both studied groups using capnogram and arterial blood gases
Postoperative sore throat according the Visual Analogue Scale (VAS)	After surgical procedure (2 and 24) hours.	Postoperative sore throat after 2 and 24 hours using the VAS score (0-10). (Zero=no pain and 10 = for the most sever pain.
Kink of the small size tube (Tritube) (Yes/No)	During surgical procedure	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)
Surgeon satisfaction instance scale (1-5)	During surgical procedure	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).

Trial Locations

Locations (1)

ACC&HGH, Hamad Medical Corporation; 🇶🇦 Doha, Doah, Qatar