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Completed

NCT Number: NCT04596735

Extubation Criteria in Patients Greater Than 59 Years of Age

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

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Key information

Conditions

Extubation Respiratory Complications

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extubation Success or Extubation requiring Intervention

    Time frame: Day 1

    Quality of extubation will be assessed using a standard rubric for all extubation.

  2. Presence or Absence of specific extubation criteria.

    Time frame: Day 1

    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

Secondary outcomes

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

    Time frame: Preoperative

    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

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

    Time frame: Preoperative

    presence of COPD

  3. Number of Participants with Preoperative Exposures (Dementia)

    Time frame: Preoperative

    presence of dementia

  4. 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)

    Time frame: Preoperative

    obstructive sleep apnea SCORE >3

  5. 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)

    Time frame: Preoperative

    STOP BANG SCORE >3

  6. Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)

    Time frame: Preoperative

    Neuro-degenerative disorders such as: amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis, Alzheimer's, Huntington's

  7. Number of Participants with Preoperative Exposures (Heart failure)

    Time frame: Preoperative

    by history or documented echo

  8. Number of Participants with Preoperative Exposures (Opioid naïve)

    Time frame: Preoperative

    by history or from electronic health record

  9. Number of Participants with Preoperative Exposures (Diabetes)

    Time frame: Preoperative

    presence of diabetes mellitus

  10. Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease

    Time frame: Preoperative

    presence of end-stage renal disease

  11. Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke

    Time frame: Preoperative

  12. Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)

    Time frame: Preoperative

  13. Number of Participants with Preoperative Exposures (Current Smoker)

    Time frame: Preoperative

    current smoker or >=20 year pack history

  14. Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)

    Time frame: Preoperative

    Anesthetic maintenance agent used at time of extubation

  15. Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker

    Time frame: during procedure

  16. Number of Participants with Preoperative Exposures (Use of Midazolam)

    Time frame: during procedure

  17. Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)

    Time frame: during procedure

  18. Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)

    Time frame: during procedure

  19. Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)

    Time frame: during procedure

  20. Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)

    Time frame: during procedure

    Qualitative measures will be used to analyze this Outcome Measure

  21. Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)

    Time frame: during procedure

    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

  22. Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)

    Time frame: during procedure

  23. Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)

    Time frame: during procedure

  24. Anesthesia Time during procedure

    Time frame: during procedure

  25. Number of Participants with Preoperative Exposures (Difficult Airway)

    Time frame: during procedure

    Difficult Airway or use of alternative airway technique other than DL because of suspected difficulty with the airway

  26. Number of Participants with Preoperative Exposures (Intracranial Procedure)

    Time frame: during procedure

  27. Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)

    Time frame: during procedure

    (PEEP) positive end-expiratory pressure >7 cmH2O for >10 minutes

  28. Number of Participants with Preoperative Exposures (Surgical Procedure)

    Time frame: during procedure

  29. Number of Participants with Preoperative Exposures (Open Abdominal)

    Time frame: during procedure

  30. Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)

    Time frame: during procedure

  31. IV fluid volume

    Time frame: during procedure

  32. volume of blood products

    Time frame: during procedure

  33. types of blood products

    Time frame: during procedure

  34. Number of Participants with Preoperative Exposures (use of colloid)

    Time frame: during procedure

  35. volume of colloid

    Time frame: during procedure

Other outcomes

  1. Hospital stay

    Time frame: day 60

    length of stay

  2. 30 day Mortality Rate

    Time frame: day 30

    30 Day mortality obtained from the chart in order to determine association with intervention required at extubation

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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