RecruitmentNCT04082377
Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Laproscopic Surgery
A study testing Recruitment maneuver with tidal volume (RM TV) and Recruitment maneuver by PEEP (RM PEEP) in people with Recruitment, run by Mansoura University at 1 site in Egypt.
Trial summary
Pneumoperitoneum with CO2 insufflation during laparoscopic surgery elevates the intrathoracic pressure through the elevation of the diaphragm, which in turn decreases the lung compliance .Alveolar recruitment (AR) refers to the dynamic process of opening collapsed lung units by increasing transpulmonary pressure. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Recruitment
- What is being tested?
- Recruitment maneuver with tidal volume (RM TV) and Recruitment maneuver by PEEP (RM PEEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2019to 1 Sep 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with American Society of Anesthesiologists (ASA) physical status I - II .
- Both sexes.
- laproscopic surgeries.
Who cannot join
- Patients younger than 20 years.
- body mass index (BMI) < 25 and > 35.
- patients with major cardiovascular problems with ejection fraction < 40 %.
- patients with chronic obstructive pulmonary diseases.
- patients with major hepatic or renal dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center
Al Mansurah, Dakahlia Governorate, 05022022225
About this study
Official title: Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Anesthesia for Laproscopic Surgery
Pneumoperitoneum with CO2 insufflation during laparoscopic surgery elevates the intrathoracic pressure through the elevation of the diaphragm, which in turn decreases the lung compliance .Alveolar recruitment (AR) refers to the dynamic process of opening collapsed lung units by increasing transpulmonary pressure. It increases the area of ventilated lung parenchyma, thus improving gas exchange and arterial oxygenation .During lung recruitment, a transient increase in transpulmonary pressure induced by an intentional increase in airway pressures, results in an increase in intrathoracic pressure and a decrease in venous return, leading to a decrease in left ventricular end-diastolic areas and in stroke volume.
Read the detailed description
Pneumoperitonium for laproscopic surgery usually result in decrease total respiratory compliance due to cranial shift of the diaphragm. Alveolar recuirtment is applied hopefully to minimize lung atlectasis and open collapsed alveoli to maintain arterial oxygenation. The anantomical proximity of lungs and heart within the chest means that any increase in intrathoracic pressure could have major effect on cardiovascular functions.Up to now, far too little attention has been paid to the decrease in left ventricular performance owing to fluctuation within the- chamber within chamber system-that preciptate stroke volume and cardiac output reduction during recruitment maneuvers.Up to our knowledge, the effect of ARM on patient heamodynamics is still unclear. in this study, we will compare two different recruitment maneuvers on patient haemodynamics during laproscopic surgery.Therefore this study is designed to investigate the effect of two individualized recruitment maneuvers during anethesia for laproscopic surgery to encourage best arterial oxygenation with the least haemodynamic compromise. Accordingly we assume that recruitment by incremental stepwise PEEP by 5cmH2o with pressure controlled ventilation may be associated with better stroke volume stability without haemodynamic alteration in comparison to incremental stepwise tidal volume by 4ml/kg during volume controlled ventilation.
- Pre-oxygenation for 5 minutes will be done in all patients and they will receive 0.02 mg/Kg midazolam, 1-2 μg/Kg fentanyl, 2-2.5 mg/kg Propofol slowly IV until loss of verbal contact. atracurium 0.5 mg/kg to facilitate proper placement of endotracheal tube. All patients will be mechanically ventilated using volume control mode (VC mode) with tidal volumes of 6 ml/ PBWT, with respiratory rate 12 breath per minute (bpm) and PEEP 5 cmH2O to keep end tidal Carbone dioxide (ETCO2) at 30-35 mmHg. Anaesthesia will be maintained in all patients using (1-1.5) minimum alveolar concentration (MAC) of Sevoflurane in O2/air mixture with FIO2 (0.4).Patients will be randomly assigned to one of two equal groups, according to computer-generated randomization sequence:
- group 1 (RM TV ): Recruitment maneuver with tidal volume .
- group 2 (RM PEEP): Recruitment maneuver with positive end expiratory pressure.
Group 1 (RM TV):
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) , RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. The ventilation protocol could be changed at any time when concerned about patient safety.
Group 2 (RM PEEP):
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver.Monitoring:
Hemodynamic monitoring : stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic oxygen delivery (DO2) and oxygen delivery index (DO2I) will be measured by Cardiac output non-invasive monitor (ICONTM, OSYPKA medical cardiotronic GMBH, Elixir, Germany). Heart rate (HR), mean arterial blood pressure (MAP), and arterial oxygen saturation (Sao2) will be measured using HP monitor.
Respiratory monitoring : calculated lung compliance (dynamic compliance = TV / (peak airway pressure - PEEP)(static compliance = TV /(plateau pressure -PEEP) , peak airway pressure and plateau pressure, calculated alveolar dead space((1.135*(Paco2-Eco2)/(paco2-0.005)), driving pressure ( plateau pressure - PEEP) and Horowitz index ((Pao2 / Fio2)*100).
Basel hemodynamic variables will be obtained before endotrachial intubation (T0), Basel respiratory variables will be obtained just after endotracheal intubation(T0), Then allvariables will be obtained after endotrachial intubation (T1), after insuflation(T2), Intraopertive (T3a= at 1st hour intraopertive, T3b= at 2nd hour intraopertive, T3c= at 3rd hour intraopertive), after desuflation of the abdomen (T4), at end of surgery(T5). At each time point, the haemodynamic parameters will be recorded as follow: just before the alveolar recruitment maneuver (ARM), after 2 minutes of ARM, after 5 minutes of ARM.
Rescue strategies:
- Intraoperative hypoxemia (Spo2< 92%): rescue will be primarily performed by ↑Fio2 by 0.1 till reach 100%.
- Intraopertive hypotension (systolic blood pressure < 90 mmHg):
- Abort ARM strategy if warranted.
- Fluid administration ( 500 cc hydroxyethyl starch or 500 cc blood transfusion if indicated).
- Noradrenaline infusion (0.1mg/kg/min) is the last resort. Postoperative follow up: hemodynamic variables will be monitored at arrival to post operative care unit (PACU) (P1), and after 2 hours (P2).Also chest x-ray to exclude postoperative complications like atlectasis or pneumothorax .
- Conditions
- Recruitment
- Being tested
- Recruitment maneuver with tidal volume (RM TV), Recruitment maneuver by PEEP (RM PEEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuver with tidal volume (RM TV)Procedure or surgery
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) Brower, et al. 1999, RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM.
Recruitment maneuver by PEEP (RM PEEP)Procedure or surgery
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, in RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver with tidal volume (RM TV) | Experimental | RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW ,RR at 7 breaths/min, PEEP at 5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. The ventilation protocol could be changed at any time when concerned about patient safety. Receives: Procedure: Recruitment maneuver with tidal volume (RM TV) |
| Recruitment maneuver by PEEP (RM PEEP) | Active comparator | The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia 5 cmH2O PEEP.
RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver. Receives: Procedure: Recruitment maneuver by PEEP (RM PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac stroke volume
Change in the stroke volume alteration by less than 10- 20% % during recruitment maneuver in anesthesia for laproscopic surgery.
Measured: During intra-operative mechanical ventilation time
Secondary outcomes (6)
Dynamic lung compliance
Change of dynamic lung compliance by more than 20% above basal.
Measured: During intra-operative mechanical ventilation time
Intraoperative oxygenation
Change of intraoperative oxygenation with oxygen delivery index more than 550 ml/min/m2.
Measured: During intra-operative mechanical ventilation time
Horowitz ratio (Pao2/Fio2)
Change of intraoperative oxygenation with Horowitz ratio more than 350.
Measured: During intra-operative mechanical ventilation time
Alveolar dead space ratio
Change of the calculated alveolar dead space ratio (vd/vt) by less than 15%.
Measured: During intra-operative mechanical ventilation time
Mean arterial blood pressure
Maintain mean blood pressure not less than 60 mmHg.
Measured: During intra-operative mechanical ventilation time
Pulmonary complications
Number of patients with postoperative pulmonary complications like atelectasis or pneumothorax.
Measured: During first 2 hours postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start5 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mahmoud Othman, Mansoura University
- Investigators
- Mahmoud M Othman, MD, Principal investigator, Faculty of medicine,Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082377
- Sponsor's protocol ID
- MD/19.06.188
- Status last verified
- Oct 2021
- First submitted
- 5 Sep 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Anesthesia for Laproscopic Surgery
- ClinicalTrials.gov ID
- NCT04082377
- Acronym / sponsor ID
- MD/19.06.188
- Conditions
- Recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 Sep 2019 (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.
Pneumoperitoneum with CO2 insufflation during laparoscopic surgery elevates the intrathoracic pressure through the elevation of the diaphragm, which in turn decreases the lung compliance .Alveolar recruitment (AR) refers to the dynamic process of opening collapsed lung units by increasing transpulmonary pressure. It increases the area of ventilated lung parenchyma, thus improving gas exchange and arterial oxygenation .During lung recruitment, a transient increase in transpulmonary pressure induced by an intentional increase in airway pressures, results in an increase in intrathoracic pressure and a decrease in venous return, leading to a decrease in left ventricular end-diastolic areas and in stroke volume.
Detailed description
Pneumoperitonium for laproscopic surgery usually result in decrease total respiratory compliance due to cranial shift of the diaphragm. Alveolar recuirtment is applied hopefully to minimize lung atlectasis and open collapsed alveoli to maintain arterial oxygenation. The anantomical proximity of lungs and heart within the chest means that any increase in intrathoracic pressure could have major effect on cardiovascular functions.Up to now, far too little attention has been paid to the decrease in left ventricular performance owing to fluctuation within the- chamber within chamber system-that preciptate stroke volume and cardiac output reduction during recruitment maneuvers.Up to our knowledge, the effect of ARM on patient heamodynamics is still unclear. in this study, we will compare two different recruitment maneuvers on patient haemodynamics during laproscopic surgery.Therefore this study is designed to investigate the effect of two individualized recruitment maneuvers during anethesia for laproscopic surgery to encourage best arterial oxygenation with the least haemodynamic compromise. Accordingly we assume that recruitment by incremental stepwise PEEP by 5cmH2o with pressure controlled ventilation may be associated with better stroke volume stability without haemodynamic alteration in comparison to incremental stepwise tidal volume by 4ml/kg during volume controlled ventilation.
- Pre-oxygenation for 5 minutes will be done in all patients and they will receive 0.02 mg/Kg midazolam, 1-2 μg/Kg fentanyl, 2-2.5 mg/kg Propofol slowly IV until loss of verbal contact. atracurium 0.5 mg/kg to facilitate proper placement of endotracheal tube. All patients will be mechanically ventilated using volume control mode (VC mode) with tidal volumes of 6 ml/ PBWT, with respiratory rate 12 breath per minute (bpm) and PEEP 5 cmH2O to keep end tidal Carbone dioxide (ETCO2) at 30-35 mmHg. Anaesthesia will be maintained in all patients using (1-1.5) minimum alveolar concentration (MAC) of Sevoflurane in O2/air mixture with FIO2 (0.4).Patients will be randomly assigned to one of two equal groups, according to computer-generated randomization sequence:
- group 1 (RM TV ): Recruitment maneuver with tidal volume .
- group 2 (RM PEEP): Recruitment maneuver with positive end expiratory pressure.
Group 1 (RM TV):
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) , RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. The ventilation protocol could be changed at any time when concerned about patient safety.
Group 2 (RM PEEP):
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver.Monitoring:
Hemodynamic monitoring : stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic oxygen delivery (DO2) and oxygen delivery index (DO2I) will be measured by Cardiac output non-invasive monitor (ICONTM, OSYPKA medical cardiotronic GMBH, Elixir, Germany). Heart rate (HR), mean arterial blood pressure (MAP), and arterial oxygen saturation (Sao2) will be measured using HP monitor.
Respiratory monitoring : calculated lung compliance (dynamic compliance = TV / (peak airway pressure - PEEP)(static compliance = TV /(plateau pressure -PEEP) , peak airway pressure and plateau pressure, calculated alveolar dead space((1.135*(Paco2-Eco2)/(paco2-0.005)), driving pressure ( plateau pressure - PEEP) and Horowitz index ((Pao2 / Fio2)*100).
Basel hemodynamic variables will be obtained before endotrachial intubation (T0), Basel respiratory variables will be obtained just after endotracheal intubation(T0), Then allvariables will be obtained after endotrachial intubation (T1), after insuflation(T2), Intraopertive (T3a= at 1st hour intraopertive, T3b= at 2nd hour intraopertive, T3c= at 3rd hour intraopertive), after desuflation of the abdomen (T4), at end of surgery(T5). At each time point, the haemodynamic parameters will be recorded as follow: just before the alveolar recruitment maneuver (ARM), after 2 minutes of ARM, after 5 minutes of ARM.
Rescue strategies:
- Intraoperative hypoxemia (Spo2< 92%): rescue will be primarily performed by ↑Fio2 by 0.1 till reach 100%.
- Intraopertive hypotension (systolic blood pressure < 90 mmHg):
- Abort ARM strategy if warranted.
- Fluid administration ( 500 cc hydroxyethyl starch or 500 cc blood transfusion if indicated).
- Noradrenaline infusion (0.1mg/kg/min) is the last resort. Postoperative follow up: hemodynamic variables will be monitored at arrival to post operative care unit (PACU) (P1), and after 2 hours (P2).Also chest x-ray to exclude postoperative complications like atlectasis or pneumothorax .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver with tidal volume (RM TV) | Experimental | Procedure: Recruitment maneuver with tidal volume (RM TV)RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW ,RR at 7 breaths/min, PEEP at 5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. The ventilation protocol could be changed at any time when concerned about patient safety. |
| Recruitment maneuver by PEEP (RM PEEP) | Active comparator | Procedure: Recruitment maneuver by PEEP (RM PEEP)The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia 5 cmH2O PEEP. RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with American Society of Anesthesiologists (ASA) physical status I - II .
- Both sexes.
- laproscopic surgeries.
Key exclusion criteria (5 listed)
- Patients younger than 20 years.
- body mass index (BMI) < 25 and > 35.
- patients with major cardiovascular problems with ejection fraction < 40 %.
- patients with chronic obstructive pulmonary diseases.
- patients with major hepatic or renal dysfunction.
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 |
|---|---|---|
| Recruitment maneuver with tidal volume (RM TV)The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP. RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) Brower, et al. 1999, RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. | Procedure or surgery | Recruitment maneuver with tidal volume (RM TV) |
| Recruitment maneuver by PEEP (RM PEEP)The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, in RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver | Procedure or surgery | Recruitment maneuver by PEEP (RM PEEP) |
Primary outcome
Cardiac stroke volume
Time frame: During intra-operative mechanical ventilation time
Change in the stroke volume alteration by less than 10- 20% % during recruitment maneuver in anesthesia for laproscopic surgery.
6 secondary outcomes
Dynamic lung compliance
Time frame: During intra-operative mechanical ventilation time
Intraoperative oxygenation
Time frame: During intra-operative mechanical ventilation time
Horowitz ratio (Pao2/Fio2)
Time frame: During intra-operative mechanical ventilation time
Alveolar dead space ratio
Time frame: During intra-operative mechanical ventilation time
Mean arterial blood pressure
Time frame: During intra-operative mechanical ventilation time
Pulmonary complications
Time frame: During first 2 hours postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Recruitment
Recruiting
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Modeling of Recruitment Curves
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Recruiting
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
Caregiver Stress, Caregiver Health Related QOL
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.
Mahmoud M Othman, MD principal investigator
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 Recruitment maneuver with tidal volume (RM TV) and Recruitment maneuver by PEEP (RM PEEP) in people with Recruitment, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac stroke volume (time frame: During intra-operative mechanical ventilation time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.