Effect of Variable Volume Ventilation on Lung Compliance

NCT03661502 | Unknown

• 1 other identifier: JPM 2018 VVV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.

Conditions

Lung Injury

Outcome Measures

Primary Outcomes (1)

• Number of lung recruitments required to keep dynamic lung compliance above 40.

  Measuring dynamic lung compliance during mechanical ventilation. When it drops below 40 a lung recruitment is done with increase of PEEP to maximum 15 cmH2O.

  during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.

Secondary Outcomes (1)

• Oxygen saturation at arrival of PACU without oxygen therapy.

  during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.

Study Arms (2)

variable tidal volume ventilation (VVV)

EXPERIMENTAL

the intervention is using a ventilation mode with variable tidal volume. The average tidal volume is 6 ml/kg and respiratory rate adapted to reach an end tidalCO2 concentration between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.

Device: VVV

Pressure controlled ventilation (PCV)

EXPERIMENTAL

the intervention is using ventilation mode with constant pressure and constant tidal volume. The tidal volume is 6 ml/kg and respiratory rate is adapted to reach end tidal CO2 concentrations between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.

Device: PCV

Interventions

VVV DEVICE

ventilation mode with variable tidal volume is chosen. the average tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg

variable tidal volume ventilation (VVV)

PCV DEVICE

ventilation mode with constant tidal volume is chosen. the tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg

Pressure controlled ventilation (PCV)

Eligibility Criteria

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

You may qualify if:

• laparoscopic bariatric surgery requiring mechanical ventilation

You may not qualify if:

• lung disease requiring oxygen before anesthesia
• emergence procedure
• spontaneous or assisted ventilation

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Marc Lanckneus

  AZ Sint-Jan AV

  STUDY CHAIR

Central Study Contacts

Jan Paul Mulier

CONTACT

003250452490; jan.mulier@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of dep anesthesia & intensive care

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)