NCT07639398

Brief Summary

Suspension laryngoscopy presents significant challenges for airway management due to the need to maintain adequate ventilation while providing optimal surgical exposure. Flow-controlled ventilation (FCV) is a novel ventilation mode that delivers constant inspiratory and expiratory flow using a narrow-lumen, cuffed endotracheal tube, potentially improving ventilation efficiency in shared-airway surgeries. This prospective observational study aims to compare flow-controlled ventilation and conventional volume-controlled ventilation in patients undergoing elective suspension laryngoscopy. Respiratory mechanics, hemodynamic parameters, perioperative pulmonary function, and procedure-related complications will be evaluated to assess the feasibility and clinical performance of FCV in this surgical setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

December 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

February 3, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

Flow Controlled VentilationVolume Controlled VentilationSuspension LaryngoscopyAirway ManegementRespiratory Mechanics

Outcome Measures

Primary Outcomes (1)

  • Peak airway pressure

    Intraoperative peak airway pressure (cmH2O) measured at predefined time intervals during suspension laryngoscopy.

    During surgery with 10 minute intervals

Secondary Outcomes (5)

  • Respiratory system compliance

    Intraoperative period during suspension laryngoscopy with 10 minute intervals.

  • End tidal carbondioxide

    Intraoperative period during suspension laryngoscopy with 10 minute intervals

  • Peripheral oxygen saturation

    Intraoperative period during suspension laryngoscopy with 10 minute intervals.

  • Forced expiratory volume in one second

    30 minutes before surgery and 12 hours after surgery

  • Forced vital capacity

    30 minutes before surgery and 12 hours after surgery

Study Arms (2)

Flow-Controlled Ventilation Group

Patients undergoing elective suspension laryngoscopy who were ventilated using flow-controlled ventilation based on the attending anesthesiologist's clinical preference.

Volume-Controlled Ventilation Group

Patients undergoing elective suspension laryngoscopy who were ventilated using conventional volume-controlled ventilation based on the attending anesthesiologist's clinical preference.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 to 65 years scheduled for elective suspension laryngoscopy under general anesthesia were included. Eligible participants had an American Society of Anesthesiologists (ASA) physical status of I-III and a body mass index between 18 and 40 kg/m². All participants provided written informed consent prior to participation.

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective suspension laryngoscopy under general anesthesia
  • Body mass index between 18 and 40 kg/m²
  • Provision of written informed consent

You may not qualify if:

  • Inability to cooperate with pulmonary function testing
  • Intraoperative hemodynamic instability or oxygen desaturation (SpO₂ \<92%)
  • Requirement for tracheostomy during the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Salih Birkan ARI, M.D.

    Ankara Trainig and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Principal investigator

Study Record Dates

First Submitted

February 3, 2026

First Posted

June 10, 2026

Study Start

December 20, 2023

Primary Completion

February 19, 2024

Study Completion

February 19, 2024

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data, as the study is an academic, single-center observational study and only aggregate data will be reported.

Locations