The Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements

NCT05224895 | Unknown

• 1 other identifier: E1-21-2231
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position. The secondary aim is to investigate the correlation between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.

Conditions

Airway Edema; Ultrasonography; Robotic Surgical Procedures; Postoperative Respiratory Complication

Keywords

Airway edema; ultrasonography; Robotic surgical procedures; Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (10)

• Preoperative Tongue thickness

  When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

  Baseline, preoperative

• postoperative Tongue thickness1

  When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

  immediately postextubation

• postoperative Tongue thickness2

  When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness

  postoperative 2. hour

• preoperative Tongue volume

  Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

  Baseline, preoperative

• postoperative Tongue volume1

  Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

  immediately postextubation

• postoperativeTongue volume2

  Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width

  postoperative 2. hour

• Preoperative Lateral parapharyngeal wall thickness

  The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

  Baseline, preoperative

• postoperative Lateral parapharyngeal wall thickness1

  The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

  immediately postextubation

• postoperative Lateral parapharyngeal wall thickness2

  The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured

  postoperative 2. hour

• Number of participants with Critical respiratory events

  A PACU critical respiratory event (CRE), any unexpected hypoxemia (hemoglobin oxygen saturation \< 90%), hypoventilation (respiratory rate \< 8 bpm or arterial carbon dioxide tension \> 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).

  Within postoperative 2 hours

Study Arms (1)

General Anesthesia in Trendelenburg position for robotic prostatectomy

Procedure: General Anesthesia in Trendelenburg position for robotic prostatectomy

Interventions

General Anesthesia in Trendelenburg position for robotic prostatectomy PROCEDURE

in this arm, changes in preoperative and postoperative airway measurements and correlation with postoperative critical airway events will be monitored.

General Anesthesia in Trendelenburg position for robotic prostatectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participants who undergo robotic prostatectomy in Ankara City Hospital

You may qualify if:

• Robotic Laparoscopic Prostatectomy
• ASA I-II-III-IV risk group -

You may not qualify if:

• contraindication of trendelenburg position,
• history of maxillofacial deformity, tumor or trauma,
• history of difficult airway,
• decompensated cardiac, respiratory, hepatic, renal disease,
• with cervical spine fracture
• patient refusal -

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Anesthesia, General; Head-Down Tilt

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• betül güven aytaç

  ankara ch bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ismail aytac

CONTACT

+905056340369; aytacismail1972@gmail.com

betül güven aytaç

CONTACT

+905073578351; drbguven@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: February 4, 2022
• Study Start: February 15, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

TU (1)