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

NCT05033730 | Unknown DMC

• 1 other identifier: MRC-01-20-164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Therapy; Complications; Trachea

Keywords

Flow Controlled Ventilation,; Tritube,; Volume Controlled Ventilation,

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)

  Intra-operatively during procedure time

• Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.

  During surgical procedure intra-operatively

• Postoperative sore throat according the Visual Analogue Scale (VAS)

  After surgical procedure (2 and 24) hours.

• Kink of the small size tube (Tritube) (Yes/No)

  During surgical procedure

• Surgeon satisfaction instance scale (1-5)

  During surgical procedure

Study Arms (2)

Standard care: Control (Group A)

NO INTERVENTION

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

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

Interventions

Flow Controlled Ventilation DEVICE

Mechanically ventilated using Flow Controlled Ventilation (FCV)

Intervention Group: (Group B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

ACC&HGH, Hamad Medical Corporation

Doha, Doah, 3050, Qatar

RECRUITING

Related Publications (3)

• 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.

  PMID: 30730422 BACKGROUND

• 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.

  PMID: 27847813 RESULT

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

  RESULT

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Nabil Shallik, M.D.

  Hamad Medical Corporation - HMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil A. Shallik, M.D.

CONTACT

+97455439264; nshallik@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 5, 2021
• Study Start: October 15, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After IRB approval directly
• Access Criteria: Website

Locations

QA (1)