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Completed

NCT Number: NCT03083457

Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation

Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.

A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.

Design: prospective, cross-over, physiological trial.

PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.

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Key information

Conditions

Anesthesia, General Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General surgery OR, A. Gemelli hospital

Rome, 00100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-II patients
  • scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)
  • Expected duration of surgery >= 150 minutes

Exclusion criteria

  • Pregnancy
  • BMI>30 kg/m^2
  • hepatic surgery
  • Cardiac failure NYHA>2
  • History of chronic respiratory failure

Treatment and study plan

Fluid resuscitation or amine administration

Drug

Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis

General anesthetic

Drug

Total intravenous anesthesia with a standard protocol

Fluid administration

Drug

3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure

Low-tidal volume ventilation

Procedure

Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study

Scheduled recruiting maneuvers

Procedure

Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP

Primary outcomes

  1. Driving Pressure

    Time frame: At the end of each 40-minute step

    Respiratory system elastic pressure (Plateau pressure-total PEEP)

Secondary outcomes

  1. Lung strain

    Time frame: At the end of each 40-minute step

    Lung static and dynamic strain

  2. Dead space

    Time frame: At the end of each 40-minute step

    Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2

  3. Oxygenation

    Time frame: At the end of each 40-minute step

    PaO2/FiO2

  4. Lung recruitment

    Time frame: At the end of each 40-minute step

    % (lung recruitment/change in end-expiratory lung volume)

  5. Lung overdistension due to PEEP

    Time frame: At the end of each 40-minute step

    % (lung overdistension/change in end-expiratory lung volume)

  6. Functional residual capacity

    Time frame: At the end of each 40-minute step

    Change in functional residual capacity due to PEEP, measured with the Nitrogen washin-washout technique

  7. Heart rate

    Time frame: At the end of each 40-minute step

    heart rate

  8. Blood pressure

    Time frame: At the end of each 40-minute step

    Arterial blood pressure

  9. Stroke volume

    Time frame: At the end of each 40-minute step

    Stroke volume, measured by pulse contour analysis

  10. Stroke volume variation

    Time frame: At the end of each 40-minute step

    Stroke volume variation, measured by pulse contour analysis

  11. Cardiac Output

    Time frame: At the end of each 40-minute step

    Stroke volume x heart rate

  12. Fluid requirements

    Time frame: At the end of each 40-minute step

    Fluid bolus requirements, according to the decision of the attending physician blinded to the design of the study

  13. Vasoactive agents

    Time frame: At the end of each 40-minute step

    Vasoactive agents requirements, according to the decision of the attending physician blinded to the design of the study

  14. Adverse events

    Time frame: At the end of each 40-minute step

    Adverse events

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Physiological Effects of Positive End-expiratory Pressure With or Without Recruiting Maneuvers in Patients Receiving Low-tidal Volume Ventilation During General Anesthesia for Open Abdominal Surgery. A Randomized, Cross-over Study

Acronym: PEEP-RM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2017
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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