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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by General Hospital Of Pyrgos
Sponsor:
Information provided by (Responsible Party):
Diamanto Aretha, General Hospital Of Pyrgos
ClinicalTrials.gov Identifier:
NCT01826968
First received: March 29, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Decreased Lung Compliance
Hypoxia
Hypercapnia
Atelectasis
Pneumonia
Procedure: Alveolar Recruitment maneuver
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section

Resource links provided by NLM:


Further study details as provided by General Hospital Of Pyrgos:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2) [ Time Frame: Before recruitment and 20 minutes after recruitment ] [ Designated as safety issue: Yes ]
  • Gas exchange change is being assessed measured as PCO2 (mmHg) and PH. [ Time Frame: Before recruitment and at 20 minutes after recruitment ] [ Designated as safety issue: Yes ]
  • Pulmonary complications [ Time Frame: up to 72 hours after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826968

Contacts
Contact: Diamanto Aretha, Consultant 00306945295782 adaretha@yahoo.gr

Locations
Greece
General Hospital of Pyrgos Recruiting
Pyrgos, Hlia, Greece, 27100
Contact: Diamanto Aretha, Consultant    00302610274789    adaretha@yahoo.gr   
Principal Investigator: Diamanto Aretha, MD, Ph.D         
Sub-Investigator: Alla Baxal, MD         
Sub-Investigator: Alexandra Mouratidou, MD         
Sub-Investigator: Panikos Protopappas, MD         
Sub-Investigator: Panagiotis Kiekkas, RN, Ph.D         
Sub-Investigator: Kalliopi Dimitrakopoulou, MD         
Sponsors and Collaborators
General Hospital Of Pyrgos
Investigators
Principal Investigator: Diamanto Aretha, MD General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
  More Information

Publications:
Responsible Party: Diamanto Aretha, Anesthesiology Consultant Grade A, MD, Ph.D, General Hospital Of Pyrgos
ClinicalTrials.gov Identifier: NCT01826968     History of Changes
Other Study ID Numbers: Lung Recruitment in Cesareans, GHPyrgosRECProt
Study First Received: March 29, 2013
Last Updated: November 14, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by General Hospital Of Pyrgos:
Lung recruitment, cesarean, lung compliance, atelectasis

Additional relevant MeSH terms:
Pulmonary Atelectasis
Hypercapnia
Pneumonia
Anoxia
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014