Extubation Criteria in Patients Greater Than 59 Years of Age

A Prospective Evaluation of Extubation Criteria in Patients Greater Than 59 Years of Age Following Anesthesia and Non-cardiac Surgery

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

Study Overview

• Status: Completed
• Conditions: Extubation; Respiratory Complications

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation Success or Extubation requiring Intervention	Quality of extubation will be assessed using a standard rubric for all extubation.	Day 1
Presence or Absence of specific extubation criteria.	Assess the presence of specific extubation criteria met during extubation from the following list: Following Commands, Tidal volume>4 cc/kg, Conjugate gaze, End-tidal CO2 (ETCO2) <55 mmHg, ET agent concentration < (Des 1%, Iso <=0.2%, Sevo <0.3%, oxygen saturation (SpO2) > 94%,Qualitative or quantitative Tetralogy of Fallot (TOF), Purposeful Movement, 5 second head lift, Spontaneous Respiratory Rate >=8 bpm at extubation, eye opening	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status	The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks	Preoperative
Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease	presence of COPD	Preoperative
Number of Participants with Preoperative Exposures (Dementia)	presence of dementia	Preoperative
Number of Participants with Preoperative Exposures (obstructive sleep apnea by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)	obstructive sleep apnea SCORE >3	Preoperative
Number of Participants with Preoperative Exposures (Sleep Disordered breathing by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)	STOP BANG SCORE >3	Preoperative
Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)	Neuro-degenerative disorders such as: amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis, Alzheimer's, Huntington's	Preoperative
Number of Participants with Preoperative Exposures (Heart failure)	by history or documented echo	Preoperative
Number of Participants with Preoperative Exposures (Opioid naïve)	by history or from electronic health record	Preoperative
Number of Participants with Preoperative Exposures (Diabetes)	presence of diabetes mellitus	Preoperative
Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease	presence of end-stage renal disease	Preoperative
Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke		Preoperative
Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)		Preoperative
Number of Participants with Preoperative Exposures (Current Smoker)	current smoker or >=20 year pack history	Preoperative
Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)	Anesthetic maintenance agent used at time of extubation	Preoperative
Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker		during procedure
Number of Participants with Preoperative Exposures (Use of Midazolam)		during procedure
Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)		during procedure
Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)		during procedure
Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)		during procedure
Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)	Qualitative measures will be used to analyze this Outcome Measure	during procedure
Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)	A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity	during procedure
Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)		during procedure
Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)		during procedure
Anesthesia Time during procedure		during procedure
Number of Participants with Preoperative Exposures (Difficult Airway)	Difficult Airway or use of alternative airway technique other than DL because of suspected difficulty with the airway	during procedure
Number of Participants with Preoperative Exposures (Intracranial Procedure)		during procedure
Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)	(PEEP) positive end-expiratory pressure >7 cmH2O for >10 minutes	during procedure
Number of Participants with Preoperative Exposures (Surgical Procedure)		during procedure
Number of Participants with Preoperative Exposures (Open Abdominal)		during procedure
Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)		during procedure
IV fluid volume		during procedure
volume of blood products		during procedure
types of blood products		during procedure
Number of Participants with Preoperative Exposures (use of colloid)		during procedure
volume of colloid		during procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	length of stay	day 60
30 day Mortality Rate	30 Day mortality obtained from the chart in order to determine association with intervention required at extubation	day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Thomas W Templeton, MD, Wake Forest Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: non-cardiac surgery; non-thoracic surgery; reintubation
• Other Study ID Numbers: IRB00063713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No