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

• Sponsor: Hamad Medical Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05033730
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilation Therapy; Complications; Trachea	Device: Flow Controlled Ventilation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between VolumeControlled Ventilation and FlowControlled Ventilation Through Ultra-thin Tube in Upper Airway Surgery
• Actual Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care: Control (Group A) 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.
Experimental: Intervention Group: (Group B) 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.	Device: Flow Controlled Ventilation; Mechanically ventilated using Flow Controlled Ventilation (FCV)

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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

1. 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

2. 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

3. 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.

4. 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)

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ACC&HGH, Hamad Medical Corporation	Doha	Doah	Qatar	3050

Sponsors and Collaborators

• Hamad Medical Corporation

Investigators

• Principal Investigator: Nabil Shallik, M.D., Hamad Medical Corporation - HMC

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Hamad Medical Corporation
• ClinicalTrials.gov Identifier: NCT05033730
• Other Study ID Numbers: MRC-01-20-164; MRC-01-20-164
• First Posted: Sep 5, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Hamad Medical Corporation: Flow Controlled Ventilation,; Tritube,; Volume Controlled Ventilation,
• Additional relevant MeSH terms: Tracheal Diseases

Study Results

No Results Posted as of Sep 5, 2021