Ventilation Strategy During General Anesthesia for Orthopedic Surgery

Not Applicable

Completed

• Conditions: Orthopedic Surgery; Ventilation
• Interventions: Procedure: High tidal Volume; Procedure: Low tidal Volume; Procedure: Low PEEP; Procedure: High PEEP

• Registration Number: NCT03657368
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study Start: 2018-09-03
• Study First Posted: 2018-09-05
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2887

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High tidal volume and high PEEP	High tidal Volume	Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.
Low tidal volume and low PEEP	Low PEEP	Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).
Low tidal volume and high PEEP	High PEEP	Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.
High tidal volume and low PEEP	High tidal Volume	Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.
High tidal volume and high PEEP	High PEEP	Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.
Low tidal volume and low PEEP	Low tidal Volume	Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).
Low tidal volume and high PEEP	Low tidal Volume	Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.
High tidal volume and low PEEP	Low PEEP	Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.

Primary Outcome Measures

Name	Time	Method
Time-weighted average SaO2/FiO2 ratio in the postanesthesia care unit (PACU)	After surgery until discharged from PACU or up to 90 minutes	Arterial oxygen saturation (SaO2) is monitored continuously in in the PACU by pulse oximetry.inspired oxygen fraction (FiO2) will be estimated from the type of device and the oxygen flow rate, using the following conversion table below. We will assume that the FiO2 remains at the same level until the time of next record.

Secondary Outcome Measures

Name	Time	Method
Composite of serious postoperative pulmonary complications	After surgery from 2 to 5 days	Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed.
Oxygenation in ward, defined as SaO2/FIO2 ratio	After surgery from 2 to 5 days	Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The overall of SaO2/FIO2 will be compared among different ventilation strategies.
Length of postoperative hospital stay	from 2 to 5 days	The number of hospitalization days will be recorded

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States