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Completed

NCT Number: NCT05361850

Comparison of Deep Versus Awake Tracheal Extubation in Adults

Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.

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Key information

Conditions

Airway Complication of Anesthesia Respiratory Complications of Care

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA physical status classification system for assessing the fitness of patients before surgery 1-3
  • Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
  • Adult patients age 18-64
  • Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
  • Scheduled cases in which tracheal intubation and general anesthesia are indicated

Exclusion criteria

  • Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
  • Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
  • Full stomach
  • Known difficult intubation or mask ventilation
  • Surgeries of the airway and intrathoracic surgeries
  • Emergent surgeries
  • Case duration >6 hours
  • Pregnancy
  • Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)
  • ASA Physical Status Classification 4 or 5
  • Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
  • Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen
  • Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)
  • Surgeries requiring prone positioning

Treatment and study plan

extubation

Procedure

Removal of the endotracheal tube

Primary outcomes

  1. Aggregate Rate of Airway and Respiratory Complications

    Time frame: Peri-extubation period

    Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration

Secondary outcomes

  1. Incidence and Severity of Postoperative Sore Throat

    Time frame: At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes

    Sore Throat Rated on 0-10 Visual Analog Scale

  2. Peri-extubation Heart Rate

    Time frame: Peri-extubation period

    Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)

  3. Peri-extubation Blood Pressure

    Time frame: Peri-extubation period

    Systolic, Diastolic, and Mean Arterial Pressure in Millimeters of Mercury by Non-Invasive Blood Pressure, Incidence and Severity of Hypertension and Hypotension (defined as 20% from Baseline Blood Pressure)

  4. End-of-Surgery to Out-Of-Room Time

    Time frame: From End-of-Surgery Time (defined by surgical dressing application) to Out-of-Room Time (defined by patient physically leaving operating room), up to two hours

    Duration in Minutes

  5. Peri-extubation Agitation

    Time frame: From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)

    Incidence of Richmond Agitation-Sedation Scale score >=2

Sponsors and collaborators

Lead sponsor

United States Navy

Fed

Registry information

Acronym: CDATE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 5, 2022
Registry last updated
May 6, 2023

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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