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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03657368
Other study ID # 18-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2018
Est. completion date November 10, 2020

Study information

Verified date May 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 2887
Est. completion date November 10, 2020
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.

Study Design


Related Conditions & MeSH terms


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 The number of hospitalization days will be recorded from 2 to 5 days
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