Ventilator LungNCT05116839
Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,
A study testing the first 15 minutes with pressure support ventilation, the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode and i gel air way in people with Ventilator Lung, run by Mansoura University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- the first 15 minutes with pressure support ventilation, the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode and i gel air way
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2019to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded.•
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Marwa Ibrahim Mohamed abdo
Al Mansurah
Marwa Ib Abdo, M.D, 01002477789, marwaibr79@yahoo.com
Marwa Abdo, M.D, 01556660553, marwaibr792000@gmail.com
About this study
Official title: 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.
Read more
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 .
Read the 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)
- Tidal volume (inspiratory \& expiratory).
- End tidal co2.
- Mean air way pressure.
- Leakage %.
- Respiratory rate .
- Spo2.
- Heart rate.
- Blood pressure (mean arterial pressure). Adverse effects;Laryngeal spasm.Blood stained device. .
- Conditions
- Ventilator Lung
- Being tested
- the first 15 minutes with pressure support ventilation, the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode, i gel air way
- Keywords
- Pressure support ventilation (CPAP) I gel
- Medical subject headings
- Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the first 15 minutes with pressure support ventilationDevice
Also called lung mechanical ventilatory mode on mechanical ventilator
PSV pressure support ventilation:triggered by minute volume < 3 Liter ,with no frequency
the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP modeDevice
Also called lung mechanical ventilatory mode on mechanical ventilator
continous positive air way pressure CPAP mode at 10 cm H2o .
i gel air wayDevice
supraglottic air way device
| Study group | Role | What they receive |
|---|---|---|
| the first 15 minutes with PSV | Placebo comparator | 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)
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 Receives: Device: the first 15 minutes with pressure support ventilation; Device: i gel air way |
| the following 15 minutes ventilation will be changed to CPAP mode | Active comparator | 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). Receives: Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode; Device: i gel air way |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 %
Measured: 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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start31 Mar 2019
- Primary completion28 Dec 2021 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a prospective cross\_over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ibrahim Mohamed Abdo,MD, Mansoura University
- Investigators
- Golnar Se Hammouda, M.D, Study chair, Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura UniversityHanaa Ma El-Bendary, M.D, Study director, Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura UniversityMarwa Ib Abdo, M.D, Principal investigator, Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura UniversityBahaa Mo Ezz, MBBCh, Principal investigator, Resident of Anesthesia Intensive Care Mansoura University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116839
- Sponsor's protocol ID
- MS/19.03.556
- Status last verified
- Nov 2021
- First submitted
- 20 Aug 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1093/bja/69.3.314.
PubMed 1389850Wong 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.
PubMed 19281479Levitan 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.
PubMed 16179048Chauhan 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.
PubMed 23493414Verghese 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.
PubMed 8712387Keller 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. doi: 10.1007/BF03012709.
PubMed 9669012Tokioka 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. doi: 10.1097/00000539-199710000-00013.
PubMed 9322456Farias 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.
PubMed 15029473Brimacombe J, Keller C, Hormann 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. doi: 10.1097/00000542-200006000-00019.
PubMed 10839911von 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.
PubMed 15673856Lim 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.
PubMed 22380745
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05116839
- Acronym / sponsor ID
- MS/19.03.556
- Conditions
- Ventilator Lung
- Keywords
- Pressure support ventilation (CPAP) I gel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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)
- Tidal volume (inspiratory \& expiratory).
- End tidal co2.
- Mean air way pressure.
- Leakage %.
- Respiratory rate .
- Spo2.
- Heart rate.
- Blood pressure (mean arterial pressure). Adverse effects;Laryngeal spasm.Blood stained device. .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a prospective cross_over study
| Arm | Type | Receives |
|---|---|---|
| the first 15 minutes with PSV | Placebo comparator | Device: the first 15 minutes with pressure support ventilation, Device: i gel air wayAll patients will breath at the first 15 minutes with PSV:triggered by minute volume <3 Liter,with with no frequency . 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 |
| the following 15 minutes ventilation will be changed to CPAP mode | Active comparator | Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode, Device: i gel air waythen 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The Patients with a body mass index (BMI) >40 or having obstructive air way disease will be excluded.•
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the first 15 minutes with pressure support ventilationAlso: lung mechanical ventilatory mode on mechanical ventilatorPSV pressure support ventilation:triggered by minute volume < 3 Liter ,with no frequency | Device | the first 15 minutes with PSV |
| the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP modeAlso: lung mechanical ventilatory mode on mechanical ventilatorcontinous positive air way pressure CPAP mode at 10 cm H2o . | Device | the following 15 minutes ventilation will be changed to CPAP mode |
| i gel air waysupraglottic air way device | Device | the first 15 minutes with PSV, the following 15 minutes ventilation will be changed to CPAP mode |
Primary outcome
Effective ventilation with PSV than does (CPAP) as regard Tidal volume
Time frame: 30 minutes
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
Effective ventilation with PSV than does (CPAP) as regard End tidal co2. on ventilator
Time frame: 30 minutes
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
Effective ventilation with PSV than does CPAP as regard Mean air way pressure
Time frame: 30 minutes
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
Effective ventilation with PSV than does (CPAP) as regard Leakage %
Time frame: 30 minutes
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
Effective ventilation with PSV than does CPAP as regard oxygen saturation.
Time frame: 30 minutes
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 %
Effective ventilation with PSV than does (CPAP) as regard respiratory rate
Time frame: 30 minutes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Background: PubMed 1389850Barker 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. doi: 10.1093/bja/69.3.314.
- Background: PubMed 19281479Wong 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.
- Background: PubMed 16179048Levitan 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.
- Background: PubMed 23493414Chauhan 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.
- Background: PubMed 8712387Verghese 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.
- Background: PubMed 9669012Keller 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. doi: 10.1007/BF03012709.
- Background: PubMed 9322456Tokioka 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. doi: 10.1097/00000539-199710000-00013.
- Background: PubMed 15029473Farias 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.
- Background: PubMed 10839911Brimacombe J, Keller C, Hormann 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. doi: 10.1097/00000542-200006000-00019.
- Background: PubMed 15673856von 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.
- Background: PubMed 22380745Lim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golnar Se Hammouda, M.D study chair
Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
Hanaa Ma El-Bendary, M.D study director
Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
Marwa Ib Abdo, M.D principal investigator
Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the first 15 minutes with pressure support ventilation, the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode and i gel air way in people with Ventilator Lung, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Ib Abdo, M.D (01002477789, marwaibr79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective ventilation with PSV than does (CPAP) as regard Tidal volume (time frame: 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116839, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.