Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,

Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gel Laryngeal Mask for Minor Surgery in Adult Patients, a Prospective cross_over Study

Introduction of Supra glottic airway devices (SAD) has revolutionized the airway management. The first successful supraglottic airway device, the Laryngeal Mask Airway(LMA).The various other SADs include ProSeal LMA, Intubating LMA and i-gel to overcome the limitations of classic Laryngeal Mask Airway( c-LMA) The risk of aspiration with c-LMA is reported tobe around 9% , pleaseboth the c-LMA and PLMA have cuff related complications. High cuff pressure in laryngeal mask airways can cause damage to the mucosae on periglottic and supraglottic structures .

Therefore, to overcome the limitations of Pro Seal Laryngeal Mask Airway (PLMA )a new and cheaper SAD called i-gel was developed. i-gel is a novel and innovative, latex free supraglottic device, made up of medical grade thermoplastic elastomer, which is soft, gel like, transparent The number of manipulations required are more in PLMA than i gel resulting in hemodynamic changes .The i-gel is comparable to PLMA insuring the airway during controlled ventilation. It is better than PLMA in terms of ease of insertion.

Spontaneous breathing is the most popular mode of ventilation with the laryngeal mask airway (LMA), but it provides less effective gas exchange than does positive pressure ventilation (PPV) . The patients receiving sevoflurane anesthesia with unassisted ventilation have a reduced rib cage contribution to ventilation, decreased tidal volume, and respiratory rate .

Pressure support ventilation (PSV) is a ventilator mode that is initiated by the patient and synchronized with the patient's respiratory effort. And may improve gaseous exchange in patients. In the intensive care unit, it is often considered the preferred mode for weaning mechanical ventilation .PSV provides more effective gas exchange than does unassisted ventilation with CPAP during anesthesia with the LMA while preserving hemodynamic homeostasis.

The use of PSV versus CPAP with the Pro Seal laryngeal mask airway in anesthetized pediatric patients revealed that PSV improved gaseous exchange and reduced work of breathing during general anesthesia PSV via Pro- Seal laryngeal mask airway improves gaseous exchange and ventilation in pediatric patients under general anesthesia more than spontaneous ventilation .

Study Overview

• Status: Recruiting
• Conditions: Ventilator Lung
• Intervention / Treatment: Device: the first 15 minutes with pressure support ventilation; Device: i gel air way; Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode

Detailed Description

Patients and Methods This prospective,cross over study will be conducted after obtaining approval from the Institutional Review Board (IRB) of faculty of medicine Mansoura University. A written informed consent will be obtained from all participants and the duration of the study will be 2 - 6 months.

Participants:

38 Adult patients with American Society of Anesthesiologists (ASA) physical status (I - II )of both sexes aged (18-65) years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study.

The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded.

All patients will be assessed on the day before surgery by detailed history thorough clinical examination, and basal laboratory investigations [Complete blood count (CBC), Coagulation profile (prothrombin time and INR), liver and renal function tests (liver enzymes, bilirubin, albumin and s. creatinine], electrocardiograph (ECG) and echo cardiography when needed.

Anaesthesia Induction of anaesthesia with fentanyl 0.5µg/kg - propofol 1mg/kg prior for insertion of device,primary success rate will be recorded.

Maintenance of anaesthesia by sevoflurane inhalation with minimal alveolar concentration (MAC) 2%.

All patients will breath spontaneously from ventilators (Dragers - Primal - germany).

All patients will breath at the first 15 minutes with PSV:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation will be changed to CPAP mode at 10 cm H2o .

Monitoring: (basal& every 3minutes)

1. Tidal volume (inspiratory & expiratory).
2. End tidal co2.
3. Mean air way pressure.
4. Leakage %.
5. Respiratory rate .
6. Spo2.
7. Heart rate.
8. Blood pressure (mean arterial pressure). Adverse effects;Laryngeal spasm.Blood stained device. .

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Ib Abdo, M.D; Phone Number: 01002477789; Email: marwaibr79@yahoo.com
• Study Contact Backup: Name: Marwa Ib Abdo, M.D; Phone Number: 01556660553; Email: marwaibr792000@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Marwa Ibrahim Mohamed Abdo
    • Contact: Marwa Ib Abdo, M.D; Phone Number: 01002477789; Email: marwaibr79@yahoo.com
    • Contact: Marwa Abdo, M.D; Phone Number: 01556660553; Email: marwaibr792000@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with (ASA) physical status I - II years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study.

Exclusion Criteria:

• The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded.•

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: the first 15 minutes with PSV; All patients will breath at the first 15 minutes with PSV:triggered by minute volume <3 Liter,with with no frequency . Monitoring: (basal&every 3minutes); Tidal volume (inspiratory & expiratory).; End tidal co2.; Mean air way pressure.; Leakage %.; Respiratory rate .; Spo2.; Heart rate.; Blood pressure (mean arterial pressure	Device: the first 15 minutes with pressure support ventilation; PSV pressure support ventilation:triggered by minute volume < 3 Liter ,with no frequency; Other Names: lung mechanical ventilatory mode on mechanical ventilator; Device: i gel air way; supraglottic air way device
Active Comparator: the following 15 minutes ventilation will be changed to CPAP mode; then the following 15 minutes ventilation will be changed to CPAP mode at 10 cm H2o . Monitoring: (basal&every 3minutes); Tidal volume (inspiratory & expiratory).; End tidal co2.; Mean air way pressure.; Leakage %.; Respiratory rate .; Spo2.; Heart rate.; Blood pressure (mean arterial pressure).	Device: i gel air way; supraglottic air way device; Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode; continous positive air way pressure CPAP mode at 10 cm H2o .; Other Names: lung mechanical ventilatory mode on mechanical ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective ventilation with PSV than does (CPAP) as regard Tidal volume	Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal& every 3minutes)Tidal volume (inspiratory & expiratory).on ventilator monitor in mil/ kilogram	30 minutes
Effective ventilation with PSV than does (CPAP) as regard End tidal co2. on ventilator	Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) End tidal co2. on ventilator ml/eq	30 minutes
Effective ventilation with PSV than does CPAP as regard Mean air way pressure	Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) Mean air way pressure.on ventilator mmhg	30 minutes
Effective ventilation with PSV than does (CPAP) as regard Leakage %	Breathing of all patients at the first 15 minutes with PSVpressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) Leakage % on ventilator monitor	30 minutes
Effective ventilation with PSV than does CPAP as regard oxygen saturation.	Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal& every 3minutes) oxygen saturation.on monitoring in %	30 minutes
Effective ventilation with PSV than does (CPAP) as regard respiratory rate	Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume <3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal& every 3minute)respiratory rate on monitor breath/ minute	30 minutes

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Golnar Se Hammouda, M.D, Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University; Study Director: Hanaa Ma El-Bendary, M.D, Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University; Principal Investigator: Marwa Ib Abdo, M.D, Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University; Principal Investigator: Bahaa Mo Ezz, MBBCh, Resident of Anesthesia Intensive Care Mansoura University Hospitals

Publications and helpful links

General Publications

• Barker P, Langton JA, Murphy PJ, Rowbotham DJ. Regurgitation of gastric contents during general anaesthesia using the laryngeal mask airway. Br J Anaesth. 1992 Sep;69(3):314-5.
• Wong JG, Heaney M, Chambers NA, Erb TO, von Ungern-Sternberg BS. Impact of laryngeal mask airway cuff pressures on the incidence of sore throat in children. Paediatr Anaesth. 2009 May;19(5):464-9. doi: 10.1111/j.1460-9592.2009.02968.x. Epub 2009 Mar 5.
• Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.
• Chauhan G, Nayar P, Seth A, Gupta K, Panwar M, Agrawal N. Comparison of clinical performance of the I-gel with LMA proseal. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):56-60. doi: 10.4103/0970-9185.105798.
• Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.
• Keller C, Sparr HJ, Luger TJ, Brimacombe J. Patient outcomes with positive pressure versus spontaneous ventilation in non-paralysed adults with the laryngeal mask. Can J Anaesth. 1998 Jun;45(6):564-7.
• Tokioka H, Nagano O, Ohta Y, Hirakawa M. Pressure support ventilation augments spontaneous breathing with improved thoracoabdominal synchrony in neonates with congenital heart disease. Anesth Analg. 1997 Oct;85(4):789-93.
• Farias JA, Frutos F, Esteban A, Flores JC, Retta A, Baltodano A, Alia I, Hatzis T, Olazarri F, Petros A, Johnson M. What is the daily practice of mechanical ventilation in pediatric intensive care units? A multicenter study. Intensive Care Med. 2004 May;30(5):918-25. doi: 10.1007/s00134-004-2225-5. Epub 2004 Mar 17.
• Brimacombe J, Keller C, Hörmann C. Pressure support ventilation versus continuous positive airway pressure with the laryngeal mask airway: a randomized crossover study of anesthetized adult patients. Anesthesiology. 2000 Jun;92(6):1621-3.
• von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.
• Lim B, Pawar D, Ng O. Pressure support ventilation vs spontaneous ventilation via ProSeal™ laryngeal mask airway in pediatric patients undergoing ambulatory surgery: a randomized controlled trial. Paediatr Anaesth. 2012 Apr;22(4):360-4. doi: 10.1111/j.1460-9592.2012.03819.x.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Anticipated): December 28, 2021
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: October 31, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pressure support ventilation (CPAP) I gel
• Other Study ID Numbers: MS/19.03.556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No