Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project

NeuroTherapia, Inc.

Status: Completed

Conditions: Ventilation; Orthopedic Surgery

Treatments: Procedure: High tidal Volume; Procedure: High PEEP; Procedure: Low tidal Volume; Procedure: Low PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT03657368

18-001

Details and patient eligibility

About

The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.

Full description

This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.

Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.

Enrollment: 2,860 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgery in orthopedic operating rooms 32-37
• General anesthesia with endotracheal intubation.

Exclusion criteria

• Non-orthopedic procedures;
• Intubation before induction of anesthesia.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,860 participants in 4 patient groups

Low tidal volume and low PEEP

Experimental group

Description:

Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).

Treatment:

Procedure: Low PEEP

Procedure: Low tidal Volume

Low tidal volume and high PEEP

Experimental group

Description:

Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.

Treatment:

Procedure: Low tidal Volume

Procedure: High PEEP

High tidal volume and low PEEP

Experimental group

Description:

Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.

Treatment:

Procedure: Low PEEP

Procedure: High tidal Volume

High tidal volume and high PEEP

Experimental group

Description:

Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.

Treatment:

Procedure: High PEEP

Procedure: High tidal Volume