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ExtubationNCT04596735

Extubation Criteria in Patients Greater Than 59 Years of Age

An observational study of Extubation and Respiratory Complications, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Extubation, Respiratory Complications
How many people
4,000 participants
Where
1 siteUnited States
Study dates
16 Oct 2020to 21 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • >= 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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

Read the 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

Keywords
non-cardiac surgery, non-thoracic surgery, reintubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04596735
Study groupRoleWhat they receive
Patients undergoing general endotracheal anesthesia that will be extubated following the procedurePatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Extubation Success or Extubation requiring Intervention

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

    Measured: Day 1

  2. 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

    Measured: Day 1

Secondary outcomes (35)

  1. 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

    Measured: Preoperative

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

    presence of COPD

    Measured: Preoperative

  3. Number of Participants with Preoperative Exposures (Dementia)

    presence of dementia

    Measured: Preoperative

  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)

    obstructive sleep apnea SCORE >3

    Measured: Preoperative

  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)

    STOP BANG SCORE >3

    Measured: Preoperative

  6. 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

    Measured: Preoperative

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

    by history or documented echo

    Measured: Preoperative

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

    by history or from electronic health record

    Measured: Preoperative

  9. Number of Participants with Preoperative Exposures (Diabetes)

    presence of diabetes mellitus

    Measured: Preoperative

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

    presence of end-stage renal disease

    Measured: Preoperative

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

    Measured: Preoperative

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

    Measured: Preoperative

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

    current smoker or >=20 year pack history

    Measured: Preoperative

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

    Anesthetic maintenance agent used at time of extubation

    Measured: Preoperative

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

    Measured: during procedure

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

    Measured: during procedure

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

    Measured: 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)

    Measured: during procedure

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

    Measured: during procedure

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

    Qualitative measures will be used to analyze this Outcome Measure

    Measured: during procedure

  21. 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

    Measured: during procedure

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

    Measured: during procedure

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

    Measured: during procedure

  24. Anesthesia Time during procedure

    Measured: during procedure

  25. 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

    Measured: during procedure

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

    Measured: during procedure

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

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

    Measured: during procedure

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

    Measured: during procedure

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

    Measured: during procedure

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

    Measured: during procedure

  31. IV fluid volume

    Measured: during procedure

  32. volume of blood products

    Measured: during procedure

  33. types of blood products

    Measured: during procedure

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

    Measured: during procedure

  35. volume of colloid

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start16 Oct 2020
  3. Primary completion21 Aug 2025
  4. Study completion21 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04596735
Sponsor's protocol ID
IRB00063713
Status last verified
Oct 2024
First submitted
14 Oct 2020
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 11035684

  • 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.

    PubMed 26215247

  • 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.

    PubMed 27185683

Questions about this trial

What is this clinical trial studying?

An observational study of Extubation and Respiratory Complications, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extubation Success or Extubation requiring Intervention (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04596735, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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