Extubation Criteria in Patients Greater Than 59 Years of Age

NCT04596735 | Completed

• 1 other identifier: IRB00063713
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Extubation; Respiratory Complications

Keywords

non-cardiac surgery; non-thoracic surgery; reintubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (35)

• Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status

  Preoperative

• Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease

  Preoperative

• Number of Participants with Preoperative Exposures (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)

  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)

  Preoperative

Other Outcomes (2)

• Hospital stay

  day 60

• 30 day Mortality Rate

  day 30

Study Arms (1)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• 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.

  PMID: 11035684 BACKGROUND

• 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.

  PMID: 26215247 BACKGROUND

• 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.

  PMID: 27185683 BACKGROUND

Study Officials

• Thomas W Templeton, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: October 16, 2020
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: August 26, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)