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Ventilation Therapy; ComplicationsNCT05033730

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

A study of Ventilation Therapy; Complications and Trachea, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ventilation Therapy; Complications, Trachea
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteQatar
Study dates
15 Oct 2020to 1 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • ASA >II
  • Advanced Respiratory disease.
  • Advanced cardiovascular disease.
  • Smokers.
  • Pregnancy.
  • Recent upper airway trauma.
Show all 9Show fewer
  • Age less than 18 years or more than 65 years.
  • Patients BMI of more than 35
  • Refuse to sign the consent.

Trial locations and contacts

1 site in 1 country.

Nabil A. Shallik, M.D. contact

+97455439264 ext. 2388

nshallik@hamad.qa

Qatar1 site, 1 recruiting

  • ACC&HGH, Hamad Medical Corporation

    Doha, Doah, 3050

    Nabil Shallik, M.D., 9745543926, nshallik@outlook.com

    Marcus Lance, M.D.

    Recruiting

Other trials in Qatar

About this study

Official title: 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.

Read the 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.

Being tested
Flow Controlled Ventilation
Keywords
Flow Controlled Ventilation,, Tritube,, Volume Controlled Ventilation,
Medical subject headings
Tracheal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flow Controlled VentilationDevice

    Mechanically ventilated using Flow Controlled Ventilation (FCV)

Study groups in NCT05033730
Study groupRoleWhat they receive
Standard care: Control (Group A)No interventionPatients 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)ExperimentalGeneral 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.
Receives: Device: Flow Controlled Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: During study time intra-operatively

  2. 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)

    Measured: During procedure time and intra-operatively

Secondary outcomes (5)

  1. 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

    Measured: Intra-operatively during procedure time

  2. 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

    Measured: During surgical procedure intra-operatively

  3. 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.

    Measured: After surgical procedure (2 and 24) hours.

  4. 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)

    Measured: During surgical procedure

  5. 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).

    Measured: During surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start15 Oct 2020
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033730
Sponsor's protocol ID
MRC-01-20-164
Other IDs
MRC-01-20-164
Status last verified
Jul 2021
First submitted
28 Jul 2021
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I will Share IPD data after IRB approval

Publications

  • 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.

    PubMed 30730422

  • 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.

    PubMed 27847813

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

Questions about this trial

What is this clinical trial studying?

A study of Ventilation Therapy; Complications and Trachea, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nabil A. Shallik, M.D. (+97455439264 ext. 2388, nshallik@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of dynamic chest wall compliance (mL/mbar) (time frame: During study time intra-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033730, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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