NCT05746949

Brief Summary

Endoscopic microsurgical procedures of the larynx (direct examination-bx, microlaryngeal resection) require the anesthesiologist and surgeon to work in the same area throughout the procedure, and while ventilation is provided during the procedure, small diameter endotracheal tubes are preferred to see the surgical area as easily as possible. However, it is sometimes observed that even conventional endotracheal tubes of this diameter make surgery difficult by obstructing the view. On the other hand, apneic laryngoscopy techniques used in upper airway surgeries, such as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia. In recent years, oxygenation has come to the fore with Transnasal High Flow Insufflation (OptiflowTM - Fischer \& Paykel Healthcare, Auckland, New Zealand), an apneic oxygenation method. This randomized study aimed to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients receiving general anaesthesia for endolaryngeal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

February 17, 2023

Last Update Submit

June 3, 2024

Conditions

OxygenpHEnd-tidal Carbon Dioxide

Keywords

high-frequency jet ventilationhigh flow nasal oxygenation

Outcome Measures

Primary Outcomes (2)

  • PaCO2 change

    PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis.

    Intraoperative

  • Ph change

    Ph changes (before preoxygenation, before induction, every 5 minutes after induction) were recorded by arterial blood gas analysis

    Intraoperative

Secondary Outcomes (6)

  • Arterial ETCO2 values

    Intraoperative

  • Nasal ETCO2 values

    Intraoperative

  • Anesthesia duration

    Intraoperative

  • Surgery time

    Intraoperative

  • Surgical satisfaction questionnaire

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

jet ventilation group

NO INTERVENTION

Jet ventilation

Optiflow group

EXPERIMENTAL

High flow nasal oxygen

Procedure: oxygenization techniques

Interventions

oxygenization techniquesPROCEDURE

to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients who will receive general anesthesia for endolaryngeal surgery.

Optiflow group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA I-II status
  • Patients who will receive general anesthesia for endolaryngeal surgery
  • \>18 years old
  • Volunteer to participate in the study

You may not qualify if:

  • \<18 years old
  • MI (EF\<%50)
  • Arrhythmia
  • Peripheral vascular disease
  • Cerebrovascular disease
  • Electrolyte disorder
  • Severe COPD
  • Chronic hypoxia
  • BMI\>35 kg/m2
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

    PMID: 25388828BACKGROUND

  • Lyons C, Callaghan M. Apnoeic oxygenation with high-flow nasal oxygen for laryngeal surgery: a case series. Anaesthesia. 2017 Nov;72(11):1379-1387. doi: 10.1111/anae.14036.

    PMID: 29047136BACKGROUND

Study Officials

  • Seda Özdağlı, Resident

    Istanbul University

    PRINCIPAL INVESTIGATOR

  • Demet Altun, Assoc. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending anesthesiologist

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

February 18, 2023

Primary Completion

June 3, 2024

Study Completion

June 4, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

TU(1)