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Completed

NCT Number: NCT04815733

Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.

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Key information

Conditions

Ventilator-Induced Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moscow Clinical Scientific Center

Moscow, Russia

About this study

The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.

Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.

Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written consent.
  • Men and women aged 18 years or more.
  • The physical status from ASA classification I, II or III.
  • BMI <= 34.9 kg / m2.
  • Low risk of respiratory complications.
  • Laparoscopic surgery in the pelvis.

Exclusion criteria

  • The physical status from ASA IV or V.
  • BMI> = 35 kg / m2.
  • Neuromuscular disease.
  • Allergy to Anesthetic Agents.
  • Operations on two cavities.
  • Operations on the chest cavity.

Treatment and study plan

Mandatory ventilation

Procedure

Use PCV-VG

pressure support ventilation

Procedure

Use PSVpro

Primary outcomes

  1. Concentrations of biomarkers of lung injury

    Time frame: 1-3 hours after surgery

    Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum

Secondary outcomes

  1. Maximum intraoperative lactate level in the early postoperative period

    Time frame: 1 hour after surgery

    Maximum intraoperative lactate level

  2. The maximum level of vasopressor support during surgery

    Time frame: From time of skin incision to time of skin closure assessed up to 24 hours

    Norepinephrine consumption (mcg/kg/h)

Other outcomes

  1. Duration of anaesthesia.

    Time frame: Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours

    Duration of anaesthesia.

  2. Procedure time

    Time frame: Period of time from intubation to extubation assessed up to 24 hours

    Length of ventilation

  3. Length of stay (LOS) in the intensive care unit (ICU).

    Time frame: Period of time from ICU arrival to discharge from ICU assessed up to 1 year

    Length of stay (LOS) in the intensive care unit (ICU).

  4. Time to reach an Aldrete score > 9 points after anaesthesia

    Time frame: Period of time from volatile anesthetic suplly stop to time when patient has more than 9 points according Aldrete score assessed up to 24 hours

    Time to reach an Aldrete score > 9 points after anaesthesia

  5. Intraoperative consumption of muscle relaxant

    Time frame: Since skin incision to skin closure assessed up to 24 hours

    mg/kg of muscle relaxant

  6. Intraoperative consumption of reversal agents.

    Time frame: Since skin incision to skin closure assessed up to 24 hours

    mg/kg of reversal agents.

  7. Supplemental oxygen in the early postoperative period

    Time frame: Since extubation up to 24 hours after extubation

    Duration of oxygen supply

  8. Quality of recovery score-40

    Time frame: 24 hours after surgery

    The QoR-40 incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale.

    QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

  9. Changes of spirometry parameter FVC after surgery

    Time frame: 1 hour and 24 hours after surgery

    FVC before surgery (L) - FVC after surgery (L)

  10. Changes of spirometry parameter FEV1 after surgery

    Time frame: 1 hour and 24 hours after surgery

    FEV1 before surgery (L)- FEV1 after surgery (L)

  11. Changes of spirometry parameter FEV1/FVC after surgery

    Time frame: 1 hour and 24 hours after surgery

    FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %)

  12. Changes of spirometry parameter PEF after surgery

    Time frame: 1 hour and 24 hours after surgery

    PEF before surgery (L/s) - PEF after surgery (L/s)

  13. Changes of spirometry parameter VC after surgery

    Time frame: 1 hour and 24 hours after surgery

    VC before surgery (L) - VC after surgery (L)

  14. Changes of spirometry parameter FEV1/VC after surgery

    Time frame: 1 hour and 24 hours after surgery

    FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %)

  15. Volume of atelectasis of lungs after surgery

    Time frame: 24 hours after surgery

    Volume of the lungs measure according to CT lung The volume of atelectasis is the difference in volumes of lungs before and after surgery

  16. The level of pain assess after surgery by Numeric Rating Scale (NRS)

    Time frame: 1 hour after surgery

    No pain - 0, worst pain - 10

  17. The level of pain assess after surgery by Numeric Rating Scale (NRS)

    Time frame: 3 hours after surgery

    No pain - 0, worst pain - 10

  18. The level of pain assess after surgery by Numeric Rating Scale (NRS)

    Time frame: 24 hours after surgery

    No pain - 0, worst pain - 10

  19. Length of stay (LOS) in hospital

    Time frame: 28 days

    Length of stay (LOS) in hospital

Sponsors and collaborators

Lead sponsor

Moscow Clinical Scientific Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2021
Registry last updated
Apr 26, 2023

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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