WithdrawnNot Applicable

Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications

Stopped: The study was stopped due to COVID restrictions on staff, therefore enrollment was not started.

United States0Started 2021-06

Plain-language summary

The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours. * No contra-indication for intra-operative volume controlled mechanical ventilation * Flat supine surgeries without expected positional adjustments * American Society of Anesthesiologists (ASA) physical status I-III Exclusion Criteria: * Use of Nitrous Oxide * BMI \> 40 * Ventilation through Nasal intubation or Tracheostomy * Preexisting sore throat, coughing, nausea/vomiting * Recent history of upper respiratory infection * Pregnancy * Expected to be kept intubated after surgery completion

What they're measuring

Minimum intracuff pressure at which there is no air leak around the cuff.

Timeframe: during surgery

Trial details

NCT IDNCT04302142

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

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