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

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

Study Overview

• Status: Completed
• Conditions: Pneumonia; Hypoxia; Hypercapnia; Atelectasis; Decreased Lung Compliance
• Intervention / Treatment: Procedure: Alveolar Recruitment maneuver

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Hlia
    • Pyrgos, Hlia, Greece, 27100
      • General Hospital of Pyrgos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
NO_INTERVENTION: Control Group; We did not used alveolar recruitment maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed	Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)	Before recruitment and 20 minutes after recruitment
Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.	Before recruitment and at 20 minutes after recruitment
Pulmonary complications	up to 72 hours after surgery

Collaborators and Investigators

• Sponsor: General Hospital Of Pyrgos
• Investigators: Principal Investigator: Diamanto Aretha, MD, General Hospital of Pyrgos, Sintriada, Pyrgos, Greece

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (ESTIMATE): April 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Lung recruitment, cesarean, lung compliance, atelectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Pulmonary Atelectasis; Hypoxia; Hypercapnia
• Other Study ID Numbers: Lung Recruitment in Cesareans; GHPyrgosRECProt (OTHER: RECProt010113)