Clinical trial NCT04557683: Perioperative Complications of Deep Extubation in Adults
Official title: Perioperative Complications of Deep Extubation in Adults Undergoing Head and Neck Surgery at Massachusetts Eye and Ear Infirmary.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Complication
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on previous published study by Asai et al, the investigators proposed that a sample size of 300 patients will enable the group to report the complication rates with adequate precision in terms of a sufficiently narrow two-sided 95% confidence interval. Potentially eligible subjects for this study are all adult patients who undergo eye and head-and-neck surgery as well as deep extubation at the end of the surgery per the discretion of the anesthesiologist assigned to the case. Deep extubation is the default extubation method practiced at MEE. Therefore, there will be a sufficient number of potentially eligible subjects to meet the target enrollment goals.

Brief summary: The investigators propose a prospective observational cohort study in order to investigate the perioperative respiratory complications of deep extubation in adults undergoing eye and head-and-neck surgery at Massachusetts Eye and Ear. Data pertaining to perioperative respiratory complications from adult patients presenting to MEE for eye and head and neck surgery who undergo deep extubation will be collected for this study.


Eligibility criteria: Inclusion Criteria:

* Adult men and women who present to MEE for eye and head-and-neck surgery and undergo deep extubation will be included.

Exclusion Criteria:

* The study does not exclude anyone from the study.

Primary outcomes:
measure: Desaturation
timeFrame: 1 hour
measure: Cough
timeFrame: 1 hour
measure: Laryngospasm
timeFrame: 1 hour
measure: Bronchospasm
timeFrame: 1 hour
measure: Negative pressure pulmonary edema
timeFrame: 1 hour
measure: Interventions
timeFrame: 1 hour
Secondary outcomes:
measure: Length of time from the end of surgery to leaving the OR
timeFrame: 1 hour
Other outcomes:
measure: Length of stay from admission to the PACU to discharge home
timeFrame: 1-3 hours
measure: Any unplanned hospital admission due to perioperative respiratory adverse events
timeFrame: 1 day
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Martha Cordoba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller KA, Harkin CP, Bailey PL. Postoperative tracheal extubation. Anesth Analg. 1995 Jan;80(1):149-72. doi: 10.1097/00000539-199501000-00025. No abstract available.
citation: Hartley M, Vaughan RS. Problems associated with tracheal extubation. Br J Anaesth. 1993 Oct;71(4):561-8. doi: 10.1093/bja/71.4.561. No abstract available.
citation: Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. doi: 10.1093/bja/80.6.767.
citation: von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Sep;30(9):529-36. doi: 10.1097/EJA.0b013e32835df608.