Perioperative Complications of Deep Extubation in Adults

Anesthesia Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557683
• Other study ID #: 1047249
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2020
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 1, 2019
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia Complication

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (4)

Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. — View Citation

Hartley M, Vaughan RS. Problems associated with tracheal extubation. Br J Anaesth. 1993 Oct;71(4):561-8. Review. — View Citation

Miller KA, Harkin CP, Bailey PL. Postoperative tracheal extubation. Anesth Analg. 1995 Jan;80(1):149-72. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay from admission to the PACU to discharge home		1-3 hours
Other	Any unplanned hospital admission due to perioperative respiratory adverse events		1 day
Primary	Desaturation	Desaturation to less than 95% for more than 10 seconds;	1 hour
Primary	Cough	Episodes of persistent cough, defined as 3 or more consecutive coughs	1 hour
Primary	Laryngospasm	Episodes of complete or partial laryngospasm	1 hour
Primary	Bronchospasm	Episodes of bronchospasm	1 hour
Primary	Negative pressure pulmonary edema	Incidence of negative pressure pulmonary edema	1 hour
Primary	Interventions	Obstruction that requires intubation or maneuvers, oral airway or jaw thrust	1 hour
Secondary	Length of time from the end of surgery to leaving the OR		1 hour