Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation

Not Applicable

Recruiting

• Conditions: Vocal Cord Disease; Vocal Cord Cyst
• Interventions: Procedure: Intubation; Device: Volume Controlled Ventilation; Device: Flow Controlled Ventilation

• Registration Number: NCT06493162
• Lead Sponsor: Kocaeli University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-29
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-09
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-05-15
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FCV Group	Intubation	Patients who will be ventilated with flow controlled ventilation following the intubation
VCV Group	Volume Controlled Ventilation	Patients who will be ventilated with volume controlled ventilation following the intubation
FCV Group	Flow Controlled Ventilation	Patients who will be ventilated with flow controlled ventilation following the intubation
VCV Group	Intubation	Patients who will be ventilated with volume controlled ventilation following the intubation

Primary Outcome Measures

Name	Time	Method
Compliance (Cdyn)	10 minutes interval after the intubation during the surgery	Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)
PIP	10 minutes interval after the intubation during the surgery	Peak inspiratory pressure
TV	10 minutes interval after the intubation during the surgery	Tidal volume
RR	10 minutes interval after the intubation during the surgery	Respiratory rate
Resistance	10 minutes interval after the intubation during the surgery	Resistance (ventilator calculates: dividing the \[peak pressure minus the plateau pressure\] by the flowrate in litres per second)

Secondary Outcome Measures

Name	Time	Method
HR	10 minutes interval after the intubation during the surgery	Heart rate
MP	10 minutes interval after the intubation during the surgery	Mean blood pressure
SpO2	10 minutes interval after the intubation during the surgery	Oxygen saturation

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey