Ventilation Strategy During General Anesthesia for Orthopedic Surgery

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03657368
• Collaborator: (none)
• Enrollment: 2,887
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 50.9
• Patients Per Site Per Month: 56.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Surgery; Ventilation	Procedure: Low tidal Volume; Procedure: High tidal Volume; Procedure: Low PEEP; Procedure: High PEEP	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2887 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Ventilation Strategy During General Anesthesia for Orthopedic Surgery
• Actual Study Start Date: Sep 3, 2018
• Actual Primary Completion Date: Nov 10, 2020
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low tidal volume and low PEEP Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).	Procedure: Low tidal Volume; Tidal volume = 6 ml/kg predicted body weight; Procedure: Low PEEP; PEEP = 5 cm H2O
Experimental: Low tidal volume and high PEEP Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.	Procedure: Low tidal Volume; Tidal volume = 6 ml/kg predicted body weight; Procedure: High PEEP; PEEP = 8 cm H2O
Experimental: High tidal volume and low PEEP Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.	Procedure: High tidal Volume; Tidal volume = 10 ml/kg predicted body weight; Procedure: Low PEEP; PEEP = 5 cm H2O
Experimental: High tidal volume and high PEEP Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.	Procedure: High tidal Volume; Tidal volume = 10 ml/kg predicted body weight; Procedure: High PEEP; PEEP = 8 cm H2O

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. Length of postoperative hospital stay [from 2 to 5 days]

Other Outcome Measures

1. Exploratory outcome: [After surgery until discharged from the hospital]

   Time from extubation to first oxygen saturation on ambient air breathing.

2. Exploratory objective: [from 2 to 5 days]

   Intraoperative estimated blood loss and perioperative transfusions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Surgery in orthopedic operating rooms 32-37

• General anesthesia with endotracheal intubation.

Exclusion Criteria:

• Non-orthopedic procedures;

• Intubation before induction of anesthesia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Alparslan Turan, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03657368
• Other Study ID Numbers: 18-001
• First Posted: Sep 5, 2018
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 8, 2022