Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial

O. Hrdy, M. Duba, A. Dolezelova, I. Roskova, M. Hlavaty, R. Traj, V. Bönisch, M. Smrcka, R. Gal

. 2023 ; 12 (1) : 32. [pub] 20230705

Status not-indexed Language English Country England, Great Britain

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc23015778

BACKGROUND: The positive effects of goal-directed hemodynamic therapy (GDHT) on patient-orientated outcomes have been demonstrated in various clinical scenarios; however, the effects of fluid management in neurosurgery remain unclear. Therefore, this study was aimed at assessing the safety and feasibility of GDHT using non-invasive hemodynamic monitoring in elective neurosurgery. The incidence of postoperative complications was compared between GDHT and control groups. METHODS: We conducted a single-center randomized pilot study with an enrollment target of 34 adult patients scheduled for elective neurosurgery. We randomly assigned the patients equally into control and GDHT groups. The control group received standard therapy during surgery and postoperatively, whereas the GDHT group received therapy guided by an algorithm based on non-invasive hemodynamic monitoring. In the GDHT group, we aimed to achieve and sustain an optimal cardiac index by using non-invasive hemodynamic monitoring and bolus administration of colloids and vasoactive drugs. The number of patients with adverse events, feasibility criteria, perioperative parameters, and incidence of postoperative complications was compared between groups. RESULTS: We successfully achieved all feasibility criteria. The GDHT protocol was safe, because no patients in either group had unsatisfactory brain tissue relaxation after surgery or brain edema requiring therapy during surgery or 24 h after surgery. Major complications occurred in two (11.8%) patients in the GDHT group and six (35.3%) patients in the control group (p = 0.105). CONCLUSIONS: Our results suggested that a large randomized trial evaluating the effects of GDHT on the incidence of postoperative complications in elective neurosurgery should be safe and feasible. The rate of postoperative complications was comparable between groups. TRIAL REGISTRATION: Trial registration: ClininalTrials.gov, registration number: NCT04754295, date of registration: February 15, 2021.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23015778
003      
CZ-PrNML
005      
20231020093630.0
007      
ta
008      
231010s2023 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1186/s13741-023-00321-3 $2 doi
035    __
$a (PubMed)37408018
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Hrdy, Ondrej $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
245    10
$a Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial / $c O. Hrdy, M. Duba, A. Dolezelova, I. Roskova, M. Hlavaty, R. Traj, V. Bönisch, M. Smrcka, R. Gal
520    9_
$a BACKGROUND: The positive effects of goal-directed hemodynamic therapy (GDHT) on patient-orientated outcomes have been demonstrated in various clinical scenarios; however, the effects of fluid management in neurosurgery remain unclear. Therefore, this study was aimed at assessing the safety and feasibility of GDHT using non-invasive hemodynamic monitoring in elective neurosurgery. The incidence of postoperative complications was compared between GDHT and control groups. METHODS: We conducted a single-center randomized pilot study with an enrollment target of 34 adult patients scheduled for elective neurosurgery. We randomly assigned the patients equally into control and GDHT groups. The control group received standard therapy during surgery and postoperatively, whereas the GDHT group received therapy guided by an algorithm based on non-invasive hemodynamic monitoring. In the GDHT group, we aimed to achieve and sustain an optimal cardiac index by using non-invasive hemodynamic monitoring and bolus administration of colloids and vasoactive drugs. The number of patients with adverse events, feasibility criteria, perioperative parameters, and incidence of postoperative complications was compared between groups. RESULTS: We successfully achieved all feasibility criteria. The GDHT protocol was safe, because no patients in either group had unsatisfactory brain tissue relaxation after surgery or brain edema requiring therapy during surgery or 24 h after surgery. Major complications occurred in two (11.8%) patients in the GDHT group and six (35.3%) patients in the control group (p = 0.105). CONCLUSIONS: Our results suggested that a large randomized trial evaluating the effects of GDHT on the incidence of postoperative complications in elective neurosurgery should be safe and feasible. The rate of postoperative complications was comparable between groups. TRIAL REGISTRATION: Trial registration: ClininalTrials.gov, registration number: NCT04754295, date of registration: February 15, 2021.
590    __
$a NEINDEXOVÁNO
655    _2
$a časopisecké články $7 D016428
700    1_
$a Duba, Milos $u Department of Neurosurgery, University Hospital Brno, Brno, Czech Republic. duba.milos@fnbrno.cz $u Department of Neurosurgery, Faculty of Medicine, Masaryk University, Brno, Czech Republic. duba.milos@fnbrno.cz
700    1_
$a Dolezelova, Andrea $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Roskova, Ivana $u Department of Neurosurgery, University Hospital Brno, Brno, Czech Republic $u Department of Neurosurgery, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Hlavaty, Martin $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Traj, Rudolf $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Bönisch, Vit $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Smrcka, Martin $u Department of Neurosurgery, University Hospital Brno, Brno, Czech Republic $u Department of Neurosurgery, Faculty of Medicine, Masaryk University, Brno, Czech Republic
700    1_
$a Gal, Roman $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
773    0_
$w MED00205974 $t Perioperative medicine (London, England) $x 2047-0525 $g Roč. 12, č. 1 (2023), s. 32
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37408018 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20231010 $b ABA008
991    __
$a 20231020093624 $b ABA008
999    __
$a ok $b bmc $g 1997258 $s 1202140
BAS    __
$a 3
BAS    __
$a PreBMC-PubMed-not-MEDLINE
BMC    __
$a 2023 $b 12 $c 1 $d 32 $e 20230705 $i 2047-0525 $m Perioperative medicine $n Perioper Med (Lond) $x MED00205974
LZP    __
$a Pubmed-20231010

Find record

Citation metrics

Archiving options