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Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance (CSRecGHPyr)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826968
First Posted: April 9, 2013
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Diamanto Aretha, General Hospital Of Pyrgos
March 29, 2013
April 9, 2013
June 23, 2015
January 2013
March 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01826968 on ClinicalTrials.gov Archive Site
  • Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2) [ Time Frame: Before recruitment and 20 minutes after recruitment ]
  • Gas exchange change is being assessed measured as PCO2 (mmHg) and PH. [ Time Frame: Before recruitment and at 20 minutes after recruitment ]
  • Pulmonary complications [ Time Frame: up to 72 hours after surgery ]
Same as current
Not Provided
Not Provided
 
Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Decreased Lung Compliance
  • Hypoxia
  • Hypercapnia
  • Atelectasis
  • Pneumonia
Procedure: Alveolar Recruitment maneuver
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.
  • Experimental: Recruitment Group
    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.
    Intervention: Procedure: Alveolar Recruitment maneuver
  • No Intervention: Control Group
    We did not used alveolar recruitment maneuver

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 42 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01826968
Lung Recruitment in Cesareans
GHPyrgosRECProt ( Other Identifier: RECProt010113 )
Yes
Not Provided
Not Provided
Diamanto Aretha, General Hospital Of Pyrgos
General Hospital Of Pyrgos
Not Provided
Principal Investigator: Diamanto Aretha, MD General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
General Hospital Of Pyrgos
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP