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

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Trachea; Ventilation Therapy; Complications

Treatments: Device: Flow Controlled Ventilation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05033730

MRC-01-20-164 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard care: Control (Group A)

No Intervention group

Description:

Patients who are scheduled for elective surgical upper airway surgery will be given General Anesthesia by an anesthesiologist who is the principal investigator and the surgical procedures will be done by the same ENT surgeon. IV Induction of Anesthesia with Propofol Target controlled infusion (TCI), Remifentanil Target controlled infusion (TCI) and Rocuronium (0.5mg/Kg) for muscle relaxation. The airway will be secured with cuffed endotracheal tube after direct laryngoscopy. After intubation by a Suitable size Endotracheal tube, they will be mechanically ventilated using Volume Controlled Ventilation (VCV) with 40% Oxygen and minute ventilation adjusted to keep ETCO2 of 40 mmHg or less, and a PEEP of 5 cmH2O.

Intervention Group: (Group B)

Experimental group

Description:

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.

Treatment:

Device: Flow Controlled Ventilation