Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation (PEEP-RM)

Catholic University of the Sacred Heart

Status: Completed

Conditions: Surgery; Anesthesia, General

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03083457

10989/15

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 6 patient groups

PEEP2 + RM

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Procedure: Scheduled recruiting maneuvers

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration

PEEP7 + RM

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Procedure: Scheduled recruiting maneuvers

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration

PEEP12 + RM

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Procedure: Scheduled recruiting maneuvers

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration

PEEP2 - RM

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration

PEEP7 - RM

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration

PEEP12 - RM.

Experimental group

Description:

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

Treatment:

Procedure: Low-tidal volume ventilation

Drug: Fluid administration

Drug: General anesthetic

Drug: Fluid resuscitation or amine administration