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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.
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of time from the end of surgery to leaving the OR | 1 hour |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Martha Cordoba, MD | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7802273 | Background | 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. | |
| 8260307 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Sep 9, 2020 | Prot_SAP_000.pdf |
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| 9771306 | 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. |
| 23344124 | 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. |