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

August 30, 2021 updated by: Hamad Medical Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nabil A. Shallik, M.D.
  • Phone Number: 2388 +97455439264
  • Email: nshallik@hamad.qa

Study Locations

  • Qatar
    • Doah
      • Doha, Doah, Qatar, 3050
        • Recruiting
        • ACC&HGH, Hamad Medical Corporation
        • Contact:
        • Sub-Investigator:
          • Marcus Lance, M.D.
        • Sub-Investigator:
          • Muhammad Al hammad, MBBCh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of dynamic chest wall compliance (mL/mbar)
Time Frame: During study time intra-operatively
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)
Time Frame: 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)
During procedure time and intra-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2020

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (ACTUAL)

September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-20-164 (OTHER: Hamad Medical Corporation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I will Share IPD data after IRB approval

IPD Sharing Time Frame

After IRB approval directly

IPD Sharing Access Criteria

Website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventilation Therapy; Complications

Clinical Trials on Flow Controlled Ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe