Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance (CSRecGHPyr)
Primary Purpose
Decreased Lung Compliance, Hypoxia, Hypercapnia
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Alveolar Recruitment maneuver
Sponsored by
About this trial
This is an interventional prevention trial for Decreased Lung Compliance focused on measuring Lung recruitment, cesarean, lung compliance, atelectasis
Eligibility Criteria
Inclusion Criteria:
- general anesthesia,
- hemodynamically stable
Exclusion Criteria:
- intracranial hypertension,
- pulmonary hypertension,
- low blood pressure (MBP<80 mmHg),
- Heart rate > 100 beats/min,
- patient refusal
Sites / Locations
- General Hospital of Pyrgos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Recruitment Group
Control Group
Arm Description
The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. In this group PEEP was set to 8 cmH2O, after the recruitment maneuver, and was left until the end of the operation.
We did not used alveolar recruitment maneuver
Outcomes
Primary Outcome Measures
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
Secondary Outcome Measures
Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)
Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.
Pulmonary complications
Full Information
NCT ID
NCT01826968
First Posted
March 29, 2013
Last Updated
June 22, 2015
Sponsor
General Hospital Of Pyrgos
1. Study Identification
Unique Protocol Identification Number
NCT01826968
Brief Title
Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
Acronym
CSRecGHPyr
Official Title
Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Of Pyrgos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O
Detailed Description
The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decreased Lung Compliance, Hypoxia, Hypercapnia, Atelectasis, Pneumonia
Keywords
Lung recruitment, cesarean, lung compliance, atelectasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recruitment Group
Arm Type
Experimental
Arm Description
The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. In this group PEEP was set to 8 cmH2O, after the recruitment maneuver, and was left until the end of the operation.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
We did not used alveolar recruitment maneuver
Intervention Type
Procedure
Intervention Name(s)
Alveolar Recruitment maneuver
Intervention Description
In this group and during recruitment maneuver the investigators used pressure control ventilation and increased inspiratory time to 50%. The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. After the maneuver PEEP was set to 8 cmH2O and was left until the end of the operation. After the end of the recruitment maneuver volume control ventilation was used until the end of the operation too.
Primary Outcome Measure Information:
Title
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
Time Frame
Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment
Secondary Outcome Measure Information:
Title
Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)
Time Frame
Before recruitment and 20 minutes after recruitment
Title
Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.
Time Frame
Before recruitment and at 20 minutes after recruitment
Title
Pulmonary complications
Time Frame
up to 72 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
general anesthesia,
hemodynamically stable
Exclusion Criteria:
intracranial hypertension,
pulmonary hypertension,
low blood pressure (MBP<80 mmHg),
Heart rate > 100 beats/min,
patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diamanto Aretha, MD
Organizational Affiliation
General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Pyrgos
City
Pyrgos
State/Province
Hlia
ZIP/Postal Code
27100
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
20608559
Citation
Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
Results Reference
background
PubMed Identifier
19443420
Citation
Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.
Results Reference
background
PubMed Identifier
16132894
Citation
Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. doi: 10.1007/s00134-005-2761-7. Epub 2005 Aug 16.
Results Reference
background
PubMed Identifier
23196259
Citation
Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
Results Reference
background
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Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
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