Perioperative Complications of Deep Extubation in Adults

Perioperative Complications of Deep Extubation in Adults Undergoing Head and Neck Surgery at Massachusetts Eye and Ear Infirmary.

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Complication

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Massachusetts Eye and Ear

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation	Desaturation to less than 95% for more than 10 seconds;	1 hour
Cough	Episodes of persistent cough, defined as 3 or more consecutive coughs	1 hour
Laryngospasm	Episodes of complete or partial laryngospasm	1 hour
Bronchospasm	Episodes of bronchospasm	1 hour
Negative pressure pulmonary edema	Incidence of negative pressure pulmonary edema	1 hour
Interventions	Obstruction that requires intubation or maneuvers, oral airway or jaw thrust	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of time from the end of surgery to leaving the OR	1 hour

Other Outcome Measures

Outcome Measure	Time Frame
Length of stay from admission to the PACU to discharge home	1-3 hours
Any unplanned hospital admission due to perioperative respiratory adverse events	1 day

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Martha Cordoba, MD, Massachusetts Eye and Ear

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 13, 2017
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1047249

Drug and device information, study documents

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