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

Primary Purpose

Ventilation Therapy; Complications, Trachea

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Flow Controlled Ventilation
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilation Therapy; Complications focused on measuring Flow Controlled Ventilation,, Tritube,, Volume Controlled Ventilation,

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • ACC&HGH, Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care: Control (Group A)

Intervention Group: (Group B)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2021
Last Updated
August 30, 2021
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05033730
Brief Title
Comparison Between VCV and FCV Through Ultra-thin Tube in Upper Airway Surgery
Official Title
Comparative Study Between VolumeControlled Ventilation and FlowControlled Ventilation Through Ultra-thin Tube in Upper Airway Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilation Therapy; Complications, Trachea
Keywords
Flow Controlled Ventilation,, Tritube,, Volume Controlled Ventilation,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care: Control (Group A)
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention Group: (Group B)
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Flow Controlled Ventilation
Intervention Description
Mechanically ventilated using Flow Controlled Ventilation (FCV)
Primary Outcome Measure Information:
Title
Measurement of dynamic chest wall compliance (mL/mbar)
Description
Dynamic chest wall compliance changes due to Flow Controlled Ventilation (FCV) in comparison to routine Volume Controlled Ventilation(VCV)
Time Frame
During study time intra-operatively
Title
Airway Resistance (mbar*s/L)
Description
This measures the airway resistance changes due to Flow Controlled Ventilation (FCV) in comparison to the traditional Volume Controlled Ventilation(VCV)
Time Frame
During procedure time and intra-operatively
Secondary Outcome Measure Information:
Title
Oxygen concentration (SPaO2)and tension(PaO2) in the blood (% and mmHg respectively)
Description
This will measure the patient oxygenation during intervention in both studied groups and using the arterial blood gases
Time Frame
Intra-operatively during procedure time
Title
Carbon dioxide in the blood (PaCO2) and the trachea (ECO2) mmHg.
Description
This measures the patient ventilation during intervention in both studied groups using capnogram and arterial blood gases
Time Frame
During surgical procedure intra-operatively
Title
Postoperative sore throat according the Visual Analogue Scale (VAS)
Description
Postoperative sore throat after 2 and 24 hours using the VAS score (0-10). (Zero=no pain and 10 = for the most sever pain.
Time Frame
After surgical procedure (2 and 24) hours.
Title
Kink of the small size tube (Tritube) (Yes/No)
Description
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)
Time Frame
During surgical procedure
Title
Surgeon satisfaction instance scale (1-5)
Description
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).
Time Frame
During surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil A. Shallik, M.D.
Phone
+97455439264
Ext
2388
Email
nshallik@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil Shallik, M.D.
Organizational Affiliation
Hamad Medical Corporation - HMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACC&HGH, Hamad Medical Corporation
City
Doha
State/Province
Doah
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabil Shallik, M.D.
Phone
9745543926
Email
nshallik@outlook.com
First Name & Middle Initial & Last Name & Degree
Marcus Lance, M.D.
First Name & Middle Initial & Last Name & Degree
Muhammad Al hammad, MBBCh
First Name & Middle Initial & Last Name & Degree
Yasser Hammad, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
I will Share IPD data after IRB approval
IPD Sharing Time Frame
After IRB approval directly
IPD Sharing Access Criteria
Website
Citations:
PubMed Identifier
30730422
Citation
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.
Results Reference
background
PubMed Identifier
27847813
Citation
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.
Results Reference
result
Citation
Jeyarajah K, Ahmad I. Awake tracheal placement of the Tritube under flexible bronchoscopic guidance. Anaesthesia Cases. 2018 Jul;6(2):1-5.
Results Reference
result

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

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