NCT03335449

Brief Summary

This Randomized controlled clinical study, entitled "Effects on Respiratory mechanics of two different ventilation strategies during Robotic- Gynecological surgery", is an original paper. The study was performed in Rome, Italy, from September 2014 to September 2015. Nowadays several studies evaluated the effects of "open lung strategy" and the positive effect of Recruitment Maneuvers and Positive End Expiratory Pressure (PEEP) application during general anesthesia, especially during open abdominal surgery and in elderly patients. This is the first study aimed at evaluating two different ventilation strategies in healthy respiratory women undergoing Robotic surgery. In particular, the investigators evaluated the effects of protective ventilation strategy on respiratory mechanics, gas exchange and post-operative respiratory complications compared to standard ventilation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

October 25, 2017

Last Update Submit

September 29, 2021

Conditions

Respiratory MechanicsMechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

  • Respiratory Compliance

    inspiratory Volume/Plateau Pressure-PEEP (ml/cmH2O)

    One year

Study Arms (2)

Protective ventilation group

EXPERIMENTAL

Protective ventilation (PV group) (Vt 6 ml/Kg of ideal body weight, PEEP 8-10 cmH 2 O and repeated recruitment maneuvers.

Other: Protective ventilation group

Standard ventilation group

NO INTERVENTION

Standard ventilation (SV group) (Tidal Volume, Vt 10 ml/Kg of ideal body weight, Positive End Expiratory Pressure, PEEP 5 cmH 2 O, no recruitment maneuvers)

Interventions

Protective ventilation groupOTHER

Application of a protective ventilation strategy in order to improve gas exchange and respiratory mechanics during Robotic surgery in deep Trendelenburg position.

Also known as: Low tidal volume, high PEEP and recruitment maneuvers
Protective ventilation group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gynecological cancer elegible for laparoscopic surgery

You may not qualify if:

  • Respiratory disease
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

    PMID: 23093163BACKGROUND

  • 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.

    PMID: 20608559BACKGROUND

  • Fahy BG, Barnas GM, Flowers JL, Nagle SE, Njoku MJ. The effects of increased abdominal pressure on lung and chest wall mechanics during laparoscopic surgery. Anesth Analg. 1995 Oct;81(4):744-50. doi: 10.1097/00000539-199510000-00015.

    PMID: 7574004BACKGROUND

  • Perilli V, Sollazzi L, Bozza P, Modesti C, Chierichini A, Tacchino RM, Ranieri R. The effects of the reverse trendelenburg position on respiratory mechanics and blood gases in morbidly obese patients during bariatric surgery. Anesth Analg. 2000 Dec;91(6):1520-5. doi: 10.1097/00000539-200012000-00041.

    PMID: 11094011BACKGROUND

  • Maracaja-Neto LF, Vercosa N, Roncally AC, Giannella A, Bozza FA, Lessa MA. Beneficial effects of high positive end-expiratory pressure in lung respiratory mechanics during laparoscopic surgery. Acta Anaesthesiol Scand. 2009 Feb;53(2):210-7. doi: 10.1111/j.1399-6576.2008.01826.x.

    PMID: 19175578BACKGROUND

  • Talab HF, Zabani IA, Abdelrahman HS, Bukhari WL, Mamoun I, Ashour MA, Sadeq BB, El Sayed SI. Intraoperative ventilatory strategies for prevention of pulmonary atelectasis in obese patients undergoing laparoscopic bariatric surgery. Anesth Analg. 2009 Nov;109(5):1511-6. doi: 10.1213/ANE.0b013e3181ba7945.

    PMID: 19843790BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician, specialist in Anesthesia and Intensive Care Medicine

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 7, 2017

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 30, 2015

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share