Peripheral venous catheter placement by pushing with saline technique

Pushing with saline technique

Peripheral venous catheter placement with the traditional method by nurses in the clinic routinely.

Traditional method

Sevcan ATAY TURAN, PhD

Ayla KAYA, PhD

Elif GÜLER, PhD

The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.

The sample of the study consists of children who aged 0-17. It is planned to collect the research data in Akdeniz University Hospital Pediatric Hematology and Oncology Outpatient Clinic. Data Collection Tools are 'Personal Information Form for Children', 'Catheterization Description Form' and 'The Difficult Intravenous Access (DIVA) Score for children '. DIVA Score will be used pre-intervention to determine whether patients have a difficult vein. Children with DIVA score of 4 and above will be randomly assigned to the intervention and control groups. The attempt to place an IV catheter in children in the intervention group will be carried out by "pushing with saline" (SF) technique. In this way, it is predicted that the success of IV intervention in difficult vascular access will increase and the number of attempts will decrease significantly. Peripheral catheter placement in the control group will be performed with the traditional method routinely implemented by nurses.

Participants will be blinded to group allocation and randomization process. Additionally they will be blinded for interventions.

The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement

The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement: A Randomized Controlled Study in a Pediatric Hematology and Oncology Sample

The form contains the catheter information regarding the children. It includes 7 questions including the time elapsed since the last vascular access, causes of catheter removal complications (infiltration, vascular damage, etc.), IV catheter location, IV catheter size (number), and peripheral vein where the catheter was placed. Primary endpoint of the study is Catheterization Description Form.

Akdeniz University

Research Assistant

Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

apatinib combine with chemotherapy. Apatinib: initial dose: 500mg,oral,once a day, after meal ( try to take the medicine at the same time each day) Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

chemotherapy Recommended chemotherapy: docetaxel(60/75 mg/m2, d1, q3w)、albuminbound paclitaxel(125mg/m2, d1, d8, q3w) or (260mg/m2, d1, q3w)。

In experimental group, the drug used with apatinib and chemotherapy.

Tao Zhang, Doctor

Tao Zhang, MD

The study is a multicenter, open-label, randomized controlled clinical study. The purpose of the study is to evaluate the efficacy and safety of apatinib combined with chemotherapy versus chemotherapy in second-line gastric cancer receiving prior anti-PD-1 therapy.

60 patients who meet the inclusion criteria will receive apatinib combine with chemotherapy or chemotherapy until the disease progresses or intolerable.

Apatinib: initial dose: 500mg,oral,once a day, after meal (try to take the medicine at the same time each day)

Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

A Prospective, Multicenter, Randomized Controlled Study of Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

OS is defined as the length of time from random assignment to death or to last contact.

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Jiangsu HengRui Medicine Co., Ltd.

Wuhan Union Hospital, China

Chief of gastrointestinal oncology

Wounds and Injuries

Musculoskeletal Diseases

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Fractures, Bone

Neoplasm Metastasis

Congenital Abnormalities

Bone Neoplasms

Neoplastic Processes

Bone Diseases

Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA

Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score

CT scans are used to generate a finite element model of patient-specific long bones. The bone model is loaded in stance position. Load based on patient's weight and the mechanical response, including the risk of fracture, is computed.

CTFEA

Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Conventional decision algorithm

Haggai Schermann, MD

Amir Sternheim, MD

Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.

Patients will be randomized to two arms and followed prospectively

Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.

The individual participant data will remain in TLVMC and will not be shared

Number of patients who became unable to ambulate for any reason. Inability to ambulate will be determined by an orthopedic surgeon from anamnesis and physical examination.

Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.

Death within 30 days after prophylactic surgery

Infection, re-operation, mechanical failure within 4 months of follow up

The number of surgeries "avoided" - presented only in the group of Intervention and only in patients without the safety endpoint within 4 months of follow up. Specifically, number of patients without the safety endpoint in whom a physician changed his/her decision to operate based on the CT-based FE analysis.

Agreement between the pathological fracture risk estimated using Mirels' scale and the pathological fracture risk CT-based FE simulation analysis. Risk levels determined by either of the estimates: low, medium, high

Number of patients who did not undergo a prophylactic surgery, in whom the CT-based FE analysis showed a risk above moderate for fractures in future and who developed a fracture during the 4 months of follow-up - calculated in both study groups.

Number of patients who underwent a prophylactic surgery, in whom the CT-based FE analysis showed a mild-moderate risk of a fracture and who devel-oped a complication (as defined in a composite safety endpoint) - calculated in both study groups

To compare proportion of patients undergoing surgery in the treatment group vs the control group.

pathological fracture during 4 months of follow up OR death within 30 days after prophylactic surgery in patients who underwent surgery OR surgical complications within 4 months of follow up: infection, re-operation, mechanical failure

Tel-Aviv Sourasky Medical Center

Skin and Connective Tissue Diseases

Nervous System Diseases

Ganglion Cysts

Headache

Post-Dural Puncture Headache

Synovial Cyst

Cysts

Pain

Neurologic Manifestations

Mucinoses

Connective Tissue Diseases

Headache Disorders

Headache Disorders, Secondary

Brain Diseases

Central Nervous System Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Lidocaine

Diclofenac

Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.

Patients will receive sphenopalatine block

Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine \& adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.

Sphenopalatine Ganglion Block

Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.

Medical Treatment

The aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.

Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study

The data will be available upon reasonable request

Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours.

VAS ranges from 0 to 10; 10 with worse outcome

Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement	NCT05685290	Nurse's Role	Pushing with sa... Traditional met...	1 Day - 17 Years	Akdeniz University
Apatinib Combined With Chemotherapy Versus Chemotherapy in Second-line Gastric Cancer Receiving Prior Anti-PD-1 Therapy	NCT05029453	Gastric Cancer Randomized Cont...	Apatinib	18 Years -	Wuhan Union Hospital, China
Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.	NCT03453905	Bone Neoplasm o... Orthopedic Diso... Bone Metastases Proximal Femora...	CTFEA Conventional de...	18 Years - 120 Years	Tel-Aviv Sourasky Medical Center
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients	NCT04657952	Sphenopalatine ... Adrenaline Post-Dural Punc... Orthopedic Randomized Cont...	Sphenopalatine ... Medical Treatme...	18 Years - 60 Years	Tanta University

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