Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation

NCT06493162 | Completed

• 1 other identifier: KAEK/05.bI.07
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times. Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred. For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.

Conditions

Vocal Cord Disease; Vocal Cord Cyst

Keywords

Microscopic Laryngeal Surgery; Flow Controlled Ventilation; Volume Controlled Ventilation

Outcome Measures

Primary Outcomes (5)

• PIP

  Peak inspiratory pressure

  10 minutes interval after the intubation during the surgery

• RR

  Respiratory rate

  10 minutes interval after the intubation during the surgery

• TV

  Tidal volume

  10 minutes interval after the intubation during the surgery

• Compliance (Cdyn)

  Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)

  10 minutes interval after the intubation during the surgery

• Resistance

  Resistance (ventilator calculates: dividing the \[peak pressure minus the plateau pressure\] by the flowrate in litres per second)

  10 minutes interval after the intubation during the surgery

Secondary Outcomes (3)

• HR

  10 minutes interval after the intubation during the surgery

• MP

  10 minutes interval after the intubation during the surgery

• SpO2

  10 minutes interval after the intubation during the surgery

Study Arms (2)

FCV Group

ACTIVE COMPARATOR

Patients who will be ventilated with flow controlled ventilation following the intubation

Procedure: Intubation; Device: Flow Controlled Ventilation

VCV Group

ACTIVE COMPARATOR

Patients who will be ventilated with volume controlled ventilation following the intubation

Procedure: Intubation; Device: Volume Controlled Ventilation

Interventions

Intubation PROCEDURE

Patients will be intubated with 5mm sized endotracheal tube for microscopic laryngeal surgery

FCV Group; VCV Group

Flow Controlled Ventilation DEVICE

Patients in FCV group will be ventilated with flow controlled ventilation mode

FCV Group

Volume Controlled Ventilation DEVICE

Patients in VCV group will be ventilated with volume controlled ventilation mode

VCV Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo elective microscopic laser surgery
• ASA status I and II

You may not qualify if:

• Surgery time more than 2 hours
• Patients with difficult intubation
• Patients with chronic lung diseases
• BMI \> 25

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)