Perioperative Complications of Deep Extubation in Adults

NCT04557683 | Completed DMC

• 1 other identifier: 1047249
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Complication

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Length of time from the end of surgery to leaving the OR

  1 hour

Other Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• The study does not exclude anyone from the study.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• 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.

  PMID: 7802273 BACKGROUND

• 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.

  PMID: 8260307 BACKGROUND

• 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.

  PMID: 9771306 BACKGROUND

• 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.

  PMID: 23344124 BACKGROUND

Study Officials

• Martha Cordoba, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: May 1, 2017
• Primary Completion: October 13, 2017
• Study Completion: March 1, 2019
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

US (1)