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

NCT03083457 | Completed

• 1 other identifier: 10989/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General; Surgery

Outcome Measures

Primary Outcomes (1)

• Driving Pressure

  Respiratory system elastic pressure (Plateau pressure-total PEEP)

  At the end of each 40-minute step

Secondary Outcomes (14)

• Lung strain

  At the end of each 40-minute step

• Dead space

  At the end of each 40-minute step

• Oxygenation

  At the end of each 40-minute step

• Lung recruitment

  At the end of each 40-minute step

• Lung overdistension due to PEEP

  At the end of each 40-minute step

Study Arms (6)

PEEP2 + RM

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers

PEEP7 + RM

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers

PEEP12 + RM

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation; Procedure: Scheduled recruiting maneuvers

PEEP2 - RM

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation

PEEP7 - RM

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation

PEEP12 - RM.

EXPERIMENTAL

General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study

Drug: Fluid resuscitation or amine administration; Drug: General anesthetic; Drug: Fluid administration; Procedure: Low-tidal volume ventilation

Interventions

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

PEEP12 + RM; PEEP12 - RM.; PEEP2 + RM; PEEP2 - RM; PEEP7 + RM; PEEP7 - RM

General anesthetic DRUG

Total intravenous anesthesia with a standard protocol

PEEP12 + RM; PEEP12 - RM.; PEEP2 + RM; PEEP2 - RM; PEEP7 + RM; PEEP7 - RM

Fluid administration DRUG

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

PEEP12 + RM; PEEP12 - RM.; PEEP2 + RM; PEEP2 - RM; PEEP7 + RM; PEEP7 - RM

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

PEEP12 + RM; PEEP12 - RM.; PEEP2 + RM; PEEP2 - RM; PEEP7 + RM; PEEP7 - RM

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

PEEP12 + RM; PEEP2 + RM; PEEP7 + RM

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

General surgery OR, A. Gemelli hospital

Rome, 00100, Italy

Location

MeSH Terms

Interventions

Anesthetics, General; Hypodermoclysis

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Study Officials

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Each patient will be randomized to receive or not scheduled recruiting maneuvers every hour. In each of the two groups, patients will receive mechanical ventilation with 3 different levels of PEEP in a sequential, randomized, cross-over manner: each period will last 40 minutes. A randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 20, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

IT (1)