Clinical trial NCT01826968: Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
Official title: Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Decreased Lung Compliance
Hypoxia
Hypercapnia
Atelectasis
Pneumonia
Keywords: Lung recruitment, cesarean, lung compliance, atelectasis
Lead sponsor: General Hospital Of Pyrgos
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
timeFrame: Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment
Secondary outcomes:
measure: Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)
timeFrame: Before recruitment and 20 minutes after recruitment
measure: Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.
timeFrame: Before recruitment and at 20 minutes after recruitment
measure: Pulmonary complications
timeFrame: up to 72 hours after surgery
Other outcomes:
Locations:
city: Pyrgos
country: Greece
facility: General Hospital of Pyrgos
state: Hlia
Study officials:
affiliation: General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
name: Diamanto Aretha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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