Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Ventilator-Induced Lung Injury Clinical Trial

Official title:

Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815733
• Other study ID #: MoscowCSC
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Moscow Clinical Scientific Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury

Intervention

Procedure:
• Mandatory ventilation
Use PCV-VG
• pressure support ventilation
Use PSVpro

Locations

Country	Name	City	State
Russian Federation	Moscow Clinical Scientific Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of anaesthesia.	Duration of anaesthesia.	Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours
Other	Procedure time	Length of ventilation	Period of time from intubation to extubation assessed up to 24 hours
Other	Length of stay (LOS) in the intensive care unit (ICU).	Length of stay (LOS) in the intensive care unit (ICU).	Period of time from ICU arrival to discharge from ICU assessed up to 1 year
Other	Time to reach an Aldrete score > 9 points after anaesthesia	Time to reach an Aldrete score > 9 points after anaesthesia	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
Other	Intraoperative consumption of muscle relaxant	mg/kg of muscle relaxant	Since skin incision to skin closure assessed up to 24 hours
Other	Intraoperative consumption of reversal agents.	mg/kg of reversal agents.	Since skin incision to skin closure assessed up to 24 hours
Other	Supplemental oxygen in the early postoperative period	Duration of oxygen supply	Since extubation up to 24 hours after extubation
Other	Quality of recovery score-40	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).	24 hours after surgery
Other	Changes of spirometry parameter FVC after surgery	FVC before surgery (L) - FVC after surgery (L)	1 hour and 24 hours after surgery
Other	Changes of spirometry parameter FEV1 after surgery	FEV1 before surgery (L)- FEV1 after surgery (L)	1 hour and 24 hours after surgery
Other	Changes of spirometry parameter FEV1/FVC after surgery	FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %)	1 hour and 24 hours after surgery
Other	Changes of spirometry parameter PEF after surgery	PEF before surgery (L/s) - PEF after surgery (L/s)	1 hour and 24 hours after surgery
Other	Changes of spirometry parameter VC after surgery	VC before surgery (L) - VC after surgery (L)	1 hour and 24 hours after surgery
Other	Changes of spirometry parameter FEV1/VC after surgery	FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %)	1 hour and 24 hours after surgery
Other	Volume of atelectasis of lungs 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	24 hours after surgery
Other	The level of pain assess after surgery by Numeric Rating Scale (NRS)	No pain - 0, worst pain - 10	1 hour after surgery
Other	The level of pain assess after surgery by Numeric Rating Scale (NRS)	No pain - 0, worst pain - 10	3 hours after surgery
Other	The level of pain assess after surgery by Numeric Rating Scale (NRS)	No pain - 0, worst pain - 10	24 hours after surgery
Other	Length of stay (LOS) in hospital	Length of stay (LOS) in hospital	28 days
Primary	Concentrations of biomarkers of lung injury	Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum	1-3 hours after surgery
Secondary	Maximum intraoperative lactate level in the early postoperative period	Maximum intraoperative lactate level	1 hour after surgery
Secondary	The maximum level of vasopressor support during surgery	Norepinephrine consumption (mcg/kg/h)	From time of skin incision to time of skin closure assessed up to 24 hours