Ventilation Strategy During General Anesthesia for Orthopedic Surgery

Orthopedic Surgery Clinical Trial

Official title:

Ventilation Strategy During General Anesthesia for Orthopedic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03657368
• Other study ID #: 18-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2887
• Est. completion date: April 2024
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Orthopedic Surgery
• Ventilation

Intervention

Procedure:
• Low tidal Volume
Tidal volume = 6 ml/kg predicted body weight
• High tidal Volume
Tidal volume = 10 ml/kg predicted body weight
• Low PEEP
PEEP = 5 cm H2O
• High PEEP
PEEP = 8 cm H2O

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome:	Time from extubation to first oxygen saturation on ambient air breathing.	After surgery until discharged from the hospital
Other	Exploratory objective:	Intraoperative estimated blood loss and perioperative transfusions.	from 2 to 5 days
Primary	Time-weighted average SaO2/FiO2 ratio in the postanesthesia care unit (PACU)	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.	After surgery until discharged from PACU or up to 90 minutes
Secondary	Composite of serious postoperative pulmonary complications	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.	After surgery from 2 to 5 days
Secondary	Oxygenation in ward, defined as SaO2/FIO2 ratio	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.	After surgery from 2 to 5 days
Secondary	Length of postoperative hospital stay		from 2 to 5 days