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

Surgery Clinical Trial

— PEEP-RM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083457
• Other study ID #: 10989/15
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Surgery

Intervention

Drug:
• Fluid resuscitation or amine administration
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
Total intravenous anesthesia with a standard protocol
• Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure

Procedure:
• Low-tidal volume ventilation
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
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

Locations

Country	Name	City	State
Italy	General surgery OR, A. Gemelli hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Pressure	Respiratory system elastic pressure (Plateau pressure-total PEEP)	At the end of each 40-minute step
Secondary	Lung strain	Lung static and dynamic strain	At the end of each 40-minute step
Secondary	Dead space	Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2	At the end of each 40-minute step
Secondary	Oxygenation	PaO2/FiO2	At the end of each 40-minute step
Secondary	Lung recruitment	% (lung recruitment/change in end-expiratory lung volume)	At the end of each 40-minute step
Secondary	Lung overdistension due to PEEP	% (lung overdistension/change in end-expiratory lung volume)	At the end of each 40-minute step
Secondary	Functional residual capacity	Change in functional residual capacity due to PEEP, measured with the Nitrogen washin-washout technique	At the end of each 40-minute step
Secondary	Heart rate	heart rate	At the end of each 40-minute step
Secondary	Blood pressure	Arterial blood pressure	At the end of each 40-minute step
Secondary	Stroke volume	Stroke volume, measured by pulse contour analysis	At the end of each 40-minute step
Secondary	Stroke volume variation	Stroke volume variation, measured by pulse contour analysis	At the end of each 40-minute step
Secondary	Cardiac Output	Stroke volume x heart rate	At the end of each 40-minute step
Secondary	Fluid requirements	Fluid bolus requirements, according to the decision of the attending physician blinded to the design of the study	At the end of each 40-minute step
Secondary	Vasoactive agents	Vasoactive agents requirements, according to the decision of the attending physician blinded to the design of the study	At the end of each 40-minute step
Secondary	Adverse events	Adverse events	At the end of each 40-minute step