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OpenTrials
Completed

NCT Number: NCT04557683

Perioperative Complications of Deep Extubation in Adults

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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Key information

Conditions

Anesthesia Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts Eye and Ear

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Desaturation

    Time frame: 1 hour

    Desaturation to less than 95% for more than 10 seconds;

  2. Cough

    Time frame: 1 hour

    Episodes of persistent cough, defined as 3 or more consecutive coughs

  3. Laryngospasm

    Time frame: 1 hour

    Episodes of complete or partial laryngospasm

  4. Bronchospasm

    Time frame: 1 hour

    Episodes of bronchospasm

  5. Negative pressure pulmonary edema

    Time frame: 1 hour

    Incidence of negative pressure pulmonary edema

  6. Interventions

    Time frame: 1 hour

    Obstruction that requires intubation or maneuvers, oral airway or jaw thrust

Secondary outcomes

  1. Length of time from the end of surgery to leaving the OR

    Time frame: 1 hour

Other outcomes

  1. Length of stay from admission to the PACU to discharge home

    Time frame: 1-3 hours

  2. Any unplanned hospital admission due to perioperative respiratory adverse events

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Sep 22, 2020
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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