Extubation Criteria in Patients Greater Than 59 Years of Age

NCT ID: NCT04596735

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-16

Study Completion Date

2025-08-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Perform a prospective observational study to evaluate routine criteria commonly used to extubate elderly patients in the operating room after non-cardiac and non-thoracic surgery to ultimately reduce the incidence of near-term reintubation and by extension other respiratory complications

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extubation Respiratory Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing general endotracheal anesthesia that will be extubated following the procedure

Patients 60 years of age and older undergoing general anesthesia and non-cardiac surgery will be observed by a member of the research team independent from the team caring for the patient at the time of emergence and extubation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>= 60 years of age
* Patients undergoing general endotracheal anesthesia for surgery or invasive diagnostic procedures that are anticipated to be extubated immediately following the procedure

Exclusion Criteria

* Age\<60 years of age
* Patients with a tracheostomy in - situ (pre-existing or placed as part of the index procedure)
* Patients undergoing cardiac surgical procedures
* Patients undergoing general endotracheal anesthesia who are not anticipated to be extubated immediately following the surgical procedure
* Patients with delayed extubations in the post anesthesia care unit or intensive care unit)
* Patients undergoing TIVA (Total Intravenous Anaesthesia)
* Patient with an initial room air SpO2\<93%
* Patients with VADS (ventricular assist device) undergoing non-cardiac surgery
* Thoracic surgical procedures
* Patients on home oxygen
* Patients getting general anesthesia with supraglottic airway
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas W Templeton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100.

Reference Type BACKGROUND
PMID: 11035684 (View on PubMed)

Alvarez MP, Samayoa-Mendez AX, Naglak MC, Yuschak JV, Murayama KM. Risk Factors for Postoperative Unplanned Intubation: Analysis of a National Database. Am Surg. 2015 Aug;81(8):820-5.

Reference Type BACKGROUND
PMID: 26215247 (View on PubMed)

Tillquist MN, Gabriel RA, Dutton RP, Urman RD. Incidence and risk factors for early postoperative reintubations. J Clin Anesth. 2016 Jun;31:80-9. doi: 10.1016/j.jclinane.2015.12.038. Epub 2016 Apr 12.

Reference Type BACKGROUND
PMID: 27185683 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00063713

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perioperative Vaping Complications
NCT05912023 ACTIVE_NOT_RECRUITING
Microaspiration and Endotracheal Tubes
NCT07017205 NOT_YET_RECRUITING NA
Preoperative Evaluation of Airway
NCT03597880 COMPLETED NA