Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter

Effect of Different Ventilation Modes on Intracranial Pressure During Laparoscopic Colectomy Guided by Optic Nerve Sheath Diameter Measurement.

Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Colectomy
• Intervention / Treatment: Device: Volume control ventilation group; Device: Pressure control ventilation-volume guaranteed group

Detailed Description

The aim of the current study is to compare the effect of volume control ventilation (VCV) versus pressure control ventilation-volume guaranteed (PCV-VG) as modes of mechanical ventilation on ICP by US guided ONSD measurement during laparoscopic colectomy,

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanaa M El Bendary; Phone Number: 00201005781768; Email: Hanaa_elbendary@yahoo.com
• Study Contact Backup: Name: Doaa G Diab; Phone Number: 00201069507088; Email: Basmalg@yahoo.com

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University
      • Contact: Hanaa M El Bendary, MD; Phone Number: 00201005781768; Email: Hanaa_elbendary@yahoo.com
      • Sub-Investigator: Maha Y Abd Allah, MD
      • Principal Investigator: Nada S Abo El Feto, M.Sec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index less than 30
• American Society of Anesthesiologist physical class I -III.

Exclusion Criteria:

• Patient refusal
• operative time < 2 hour (h)
• Patients with preexisting eye disease.
• History of eye surgery
• Optic nerve disease.
• Causes of elevated ICP.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Volume control ventilation group; Patients' lungs will be ventilated with volume control ventilation mode	Device: Volume control ventilation group; Volume control ventilation mode
Active Comparator: Pressure control ventilation-volume guaranteed group; patients' lungs will be ventilated with Pressure control ventilation-volume guaranteed mode	Device: Pressure control ventilation-volume guaranteed group; Pressure control ventilation-volume guaranteed mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)	ONSD is the acronym of O(optic) N(nerve) S(sheath) D(diameter), that ONSD is a non invasive method for measurement of intracranial pressure The optimal cutoff value has not been established, they vary between 4.85 and 5.9 mm and >5.9 mm is a sure sign of increased intracranial tension	Changes from baseline, till 30 minutes after recovery from anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	is allowed to swing within 20% of the basal value	Changes from baseline, till 30 minutes after recovery from anaesthesia
Mean arterial blood pressure	is allowed to swing within 20% of the basal value	Changes from baseline, till 30 minutes after recovery from anaesthesia
Peak airway pressure	Peak airway pressure values should not exceed 30 cm H2O. Values greater than 40 cm H2O may be harmful to the normal lung. Peak pressure applies when there is airflow in the circuit, i.e.the maximum pressure during inspiration . What determines the peak pressure is the airway resistance in the lungs. So if there is a problem with the airways the peak pressure will rise.	intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Plateau airway pressure	Plateau pressure is the pressure applied to small airways and alveoli during positive-pressure mechanical ventilation.when there is no air flow in the circuit. That is when inspiration is complete. This pressure is determined by the lung compliance. So it follows that if there is a problem with the compliance the plateau pressure will rise. Plateau pressure is measured during an inspiratory pause on the mechanical ventilator. Pplat is never bigger than PIP and is typically <10 cm H2O lower than PIP when airway resistance is not elevated.	intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
mean airway pressure	mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma	intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Dynamic Lung compliance	dynamic lung compliance Cdyn = VT / (PIP - PEEP)…..change in volume/change in pressure, where airflow resistance becomes a factor. which ranges physiologically in adults between 50 - 80 ml/cm H2O while for intubated, mechanically ventilated adults is about 30 to 40 ml/cm H2O	intra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).
Static Lung compliance	static compliance and dynamic compliance static lung compliance....Cstat = VT/ ( Pplat - PEEP) ….change in volume/change in pressure when there is no air flow..... The physiological Cstat for adult is 70 - 100 while for intubated, mechanically ventilated adults is about 50 to 60 ml/cm H2O	intra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).
pH	PH ranges normally between 7.35 - 7.45 when >7.45 it is alkalosis when <7.35 it is acidosis	Changes from baseline, till 30 min after recovery from anesthesia.
PaCO2 (carbon dioxide tension)	PaCo2 which ranges normally between 35 -45 mmHg it increase above 45 with causes of hypercapnia as hypoventilation and insufflation with Co2 and decrease below 35 with hypotension, hypo-perfusion and excessive hyperventilation Normal PaCO2-EtCO2 difference is 2-5 mmHg	Changes from baseline, till 30 min after recovery from anesthesia.
Headache	the severity of headache will be recorded using visual analogue score (where 0 = no pain and 10 = worst pain imaginable), mild headache pain will be defined by scores 1-4, moderate; by scores 5-7, and severe; by scores 8-10.	for 24 hour after surgery
Postoperative nausea and vomiting	Nausea will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) and also the incidence of vomiting will be recorded by asking a questionnaire to all patients; is vomiting present or absent.	for 24 hour after surgery
PaO2 (partial pressure of arterial oxygen)	PaO2 should= FiO2 x 500 (e.g. 0.21 x 500 = 105 mmHg)	Changes from baseline, till 30 min after recovery from anesthesia

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Hanaa M El Bendary, Assistant professor, MD anesthesia Department, Faculty of Medicine,; Study Chair: Doaa G Diab, professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ventilation; intracranial pressure; laparoscopy
• Other Study ID Numbers: MD/ 21.10.553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: will be available within 6 months of study completion
• IPD Sharing Access Criteria: data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement
• IPD Sharing Supporting Information Type: SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No