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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05268900
Enrollment
78
Registered
2022-03-07
Start date
2022-04-30
Completion date
2023-04-30
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Colectomy

Keywords

ventilation; intracranial pressure; laparoscopy

Brief summary

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.

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,

Interventions

DEVICEVolume control ventilation group

Volume control ventilation mode

DEVICEPressure control ventilation-volume guaranteed group

Pressure control ventilation-volume guaranteed mode

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in ONSD O(optic) N(nerve) S(sheath) D(diameter)Changes from baseline, till 30 minutes after recovery from anaesthesiaONSD 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

Secondary

MeasureTime frameDescription
Heart rateChanges from baseline, till 30 minutes after recovery from anaesthesiais allowed to swing within 20% of the basal value
Mean arterial blood pressureChanges from baseline, till 30 minutes after recovery from anaesthesiais allowed to swing within 20% of the basal value
Peak airway pressureintra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).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.
Plateau airway pressureintra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).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.
Dynamic Lung complianceintra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).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
mean airway pressureintra-operative changes from time of induction of anesthesia and intubation (post induction), till the end of surgery (before extubation).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
pHChanges from baseline, till 30 min after recovery from anesthesia.PH ranges normally between 7.35 - 7.45 when \>7.45 it is alkalosis when \<7.35 it is acidosis
PaCO2 (carbon dioxide tension)Changes from baseline, till 30 min after recovery from anesthesia.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
Headachefor 24 hour after surgerythe 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.
Postoperative nausea and vomitingfor 24 hour after surgeryNausea 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.
PaO2 (partial pressure of arterial oxygen)Changes from baseline, till 30 min after recovery from anesthesiaPaO2 should= FiO2 x 500 (e.g. 0.21 x 500 = 105 mmHg)
Static Lung complianceintra-operative changes from (post induction) just after induction of anesthesia and intubation, till the end of surgery (before extubation).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

Countries

Egypt

Contacts

Primary ContactHanaa M El Bendary
Hanaa_elbendary@yahoo.com00201005781768
Backup ContactDoaa G Diab
Basmalg@yahoo.com00201069507088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026