Comparison of Deep Versus Awake Tracheal Extubation in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2023-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Awake Endotracheal Intubation in Cervical Injury

NCT05619965

Trauma Patient Satisfaction Airway Morbidity

UNKNOWN NA

Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy

NCT00771784

Neurological Diseases, Heart or Respiratory Failure, Sepsis, Trauma.

COMPLETED

Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study

NCT06018220

Tracheostomy Complication

RECRUITING

Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Endotracheal Intubation

NCT05635500

Intubation; Difficult or Failed

COMPLETED NA

Ramped Versus Supine Position for Emergent Endotracheal Intubation in Adult Patients; Prospective, Randomized, Comparative Study

NCT06924411

Intubation Complications

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Complication of Anesthesia Respiratory Complications of Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Awake Extubation

Removal of the endotracheal tube while the patient is no longer under general anesthesia

Group Type ACTIVE_COMPARATOR

Extubation

Intervention Type PROCEDURE

Removal of the endotracheal tube

Deep Extubation

Removal of the endotracheal tube while the patient is under general anesthesia

Group Type ACTIVE_COMPARATOR

Extubation

Intervention Type PROCEDURE

Removal of the endotracheal tube

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extubation

Removal of the endotracheal tube

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes