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Clinical Trials/NCT06493162
NCT06493162RecruitingNot Applicable

Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial

Kocaeli University2 sites in 1 country68 target enrollmentStarted: August 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
68
Locations
2
Primary Endpoint
Compliance (Cdyn)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Compliance (Cdyn)

Time Frame: 10 minutes interval after the intubation during the surgery

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

PIP

Time Frame: 10 minutes interval after the intubation during the surgery

Peak inspiratory pressure

TV

Time Frame: 10 minutes interval after the intubation during the surgery

Tidal volume

RR

Time Frame: 10 minutes interval after the intubation during the surgery

Respiratory rate

Resistance

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hadi Ufuk Yörükoğlu

Principal investigator

Kocaeli University

Study Sites (2)

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