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出境医 / 临床实验 / Optical Nerve Sheath Changes During Head Down Laparoscopy

Optical Nerve Sheath Changes During Head Down Laparoscopy

Study Description
Brief Summary:

Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema.

Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.


Condition or disease Intervention/treatment
Intracranial Hypertension Brain Edema Pneumoperitoneum Surgery, Laparoscopic Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
Actual Study Start Date : May 13, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 30, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Steep Trendelenburg
Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)
 Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position.

In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine
Healthy controls
Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)
 Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position.

In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine
Outcome Measures
Primary Outcome Measures :
  1. Optical nerve sheath diameter changes during steep Trendelenburg position [ Time Frame: 2 months ]
    changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective laparoscopic radical prostatectomy
Criteria

Inclusion Criteria:

  • patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position
  • American Society of Anesthesiologists risk I-III

Exclusion Criteria:

  • Age <18 or >70 years
  • American Society of Anesthesiologists risk >III
  • Assumption of beta-2-blockers, diuretics
  • Heart failure with NYHA class ≥ IIb
  • Diabetes with ocular (i.e. retinopathy), neurologic (i.e. peripheral neuropathy), or renal complications
  • History of cardiac surgery, thoracic surgery, suprainguinal vascular surgery, head surgery, ocular surgery, stroke, hydrocephalus.
Contacts and Locations

Locations
Layout table for location information
Italy
ASST Fatebenefratelli Sacco, Luigi Sacco Hospital
Milan, Italy, 20157
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
Tracking Information
First Submitted Date May 19, 2019
First Posted Date May 21, 2019
Last Update Posted Date January 5, 2021
Actual Study Start Date May 13, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2019) 		Optical nerve sheath diameter changes during steep Trendelenburg position [ Time Frame: 2 months ]
changes of optical nerve sheath diameter in millimeters measured by ultrasound in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers
Original Primary Outcome Measures
 (submitted: May 19, 2019) 		Optical nerve sheath diameter changes during steep Trendelenburg position [ Time Frame: 2 months ]
To measure the optical nerve sheath diameter variations in patients undergoing laparoscopic radical prostatectomy and in healthy volunteers
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optical Nerve Sheath Changes During Head Down Laparoscopy
Official Title Optical Nerve Sheath Diameter Changes During Steep Trendelenburg Position for Laparoscopic Prostatectomy
Brief Summary

Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema.

Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients undergoing elective laparoscopic radical prostatectomy
Condition
  • Intracranial Hypertension
  • Brain Edema
  • Pneumoperitoneum
  • Surgery, Laparoscopic
Intervention Diagnostic Test: Optical nerve sheath diameter ultrasound measurement

In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position.

In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine
Study Groups/Cohorts
  • Steep Trendelenburg
    Patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position (25 degrees head down position)
    Intervention: Diagnostic Test: Optical nerve sheath diameter ultrasound measurement
  • Healthy controls
    Healthy awake volunteers undergoing steep Trendelenburg position (25 degrees head down position)
    Intervention: Diagnostic Test: Optical nerve sheath diameter ultrasound measurement
Publications *
  • Guillonneau B, Cathelineau X, Barret E, Rozet F, Vallancien G. Laparoscopic radical prostatectomy: technical and early oncological assessment of 40 operations. Eur Urol. 1999;36(1):14-20.
  • Gainsburg DM, Wax D, Reich DL, Carlucci JR, Samadi DB. Intraoperative management of robotic-assisted versus open radical prostatectomy. JSLS. 2010 Jan-Mar;14(1):1-5. doi: 10.4293/108680810X12674612014266.
  • Halverson A, Buchanan R, Jacobs L, Shayani V, Hunt T, Riedel C, Sackier J. Evaluation of mechanism of increased intracranial pressure with insufflation. Surg Endosc. 1998 Mar;12(3):266-9.
  • Awad AA, Ghobashy MA, Ouda W, Stout RG, Silverman DG, Shelley KH. Different responses of ear and finger pulse oximeter wave form to cold pressor test. Anesth Analg. 2001 Jun;92(6):1483-6.
  • Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2019) 		20
Original Estimated Enrollment Same as current
Actual Study Completion Date July 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position
  • American Society of Anesthesiologists risk I-III

Exclusion Criteria:

  • Age <18 or >70 years
  • American Society of Anesthesiologists risk >III
  • Assumption of beta-2-blockers, diuretics
  • Heart failure with NYHA class ≥ IIb
  • Diabetes with ocular (i.e. retinopathy), neurologic (i.e. peripheral neuropathy), or renal complications
  • History of cardiac surgery, thoracic surgery, suprainguinal vascular surgery, head surgery, ocular surgery, stroke, hydrocephalus.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957837
Other Study ID Numbers RIA02/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Riccardo Colombo, ASST Fatebenefratelli Sacco
Study Sponsor ASST Fatebenefratelli Sacco
Collaborators Not Provided
Investigators Not Provided
PRS Account ASST Fatebenefratelli Sacco
Verification Date January 2021

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