NCT02261428

Brief Summary

The study compares the effectiveness of Tiemann and Suction catheters, with regard to attempts to enter the trachea and the time required for the procedure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

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

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

September 30, 2014

Results QC Date

October 13, 2014

Last Update Submit

March 15, 2015

Conditions

Muscle Weakness

Keywords

Nasotracheal suction, tracheal access

Outcome Measures

Primary Outcomes (1)

  • Number of Attempts Before Entering Trachea

    We count the required attempts to insert catheter into trachea (number of attempts)

    An average of 15 seconds

Secondary Outcomes (6)

  • Time to Entering Trachea

    An average of 15 seconds

  • Respiratory Rate Immediately After Intervention

    Within 2 seconds after catheter withdrawal.

  • Heart Rate Immediately After Intervention

    Within 2 seconds after catheter withdrawal.

  • Systolic Blood Pressure Immediately After Each Intervention

    Within 2 seconds after catheter withdrawal.

  • Diastolic Blood Pressure Immediately After Each Intervention

    Within 2 seconds after catheter withdrawal.

  • +1 more secondary outcomes

Study Arms (2)

Catheter Tiemann

EXPERIMENTAL

We tested the ability of Tiemman catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention

Device: Catheter Tiemann

Suction catheter

ACTIVE COMPARATOR

We tested the ability of suction catheter to access trachea and aspirate bronchial secretions, measuring number of attempts and time required for the intervention

Device: Suction catheter

Interventions

Catheter TiemannDEVICE

We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients

Catheter Tiemann
Suction catheterDEVICE

We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients

Suction catheter

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients with nasogastric tube and spontaneous breathing without artificial airway
  • Inability to mobilize and handle secretions
  • Glasgow Coma Scale (GCS) \>12/15
  • PaO2/FiO2 ratio \>100

You may not qualify if:

  • Active nasal bleeding
  • international normalized ratio (INR)\>3
  • Glasgow Coma Scale (GCS) \<11/15
  • Facial or basal cranial fractures
  • Tumor in trachea
  • Pregnancy
  • ICU patients with endotracheal tube or tracheostomy tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Pode D, Manny J. A simplified method for repeated nasotracheal suction. Surg Gynecol Obstet. 1984 Aug;159(2):173-4.

    PMID: 6463830BACKGROUND

  • Brucia J, Rudy E. The effect of suction catheter insertion and tracheal stimulation in adults with severe brain injury. Heart Lung. 1996 Jul-Aug;25(4):295-303. doi: 10.1016/s0147-9563(96)80065-3.

    PMID: 8836745BACKGROUND

  • Gemma M, Tommasino C, Cerri M, Giannotti A, Piazzi B, Borghi T. Intracranial effects of endotracheal suctioning in the acute phase of head injury. J Neurosurg Anesthesiol. 2002 Jan;14(1):50-4. doi: 10.1097/00008506-200201000-00010.

    PMID: 11773824BACKGROUND

  • Marlow TJ, Goltra DD Jr, Schabel SI. Intracranial placement of a nasotracheal tube after facial fracture: a rare complication. J Emerg Med. 1997 Mar-Apr;15(2):187-91. doi: 10.1016/s0736-4679(96)00356-3.

    PMID: 9144060BACKGROUND

  • Sloan EP, VanRooyen MJ. Suction catheter-assisted nasotracheal intubation. Acad Emerg Med. 1994 Jul-Aug;1(4):388-90. doi: 10.1111/j.1553-2712.1994.tb02651.x.

    PMID: 7614287BACKGROUND

  • Roppolo LP, Vilke GM, Chan TC, Krishel S, Hayden SR, Rosen P, Trione M. Nasotracheal intubation in the emergency department, revisited. J Emerg Med. 1999 Sep-Oct;17(5):791-9. doi: 10.1016/s0736-4679(99)00085-2.

    PMID: 10499691BACKGROUND

  • Saissy JM, Boussignac G, Cheptel E, Rouvin B, Fontaine D, Bargues L, Levecque JP, Michel A, Brochard L. Efficacy of continuous insufflation of oxygen combined with active cardiac compression-decompression during out-of-hospital cardiorespiratory arrest. Anesthesiology. 2000 Jun;92(6):1523-30. doi: 10.1097/00000542-200006000-00007.

    PMID: 10839900BACKGROUND

  • Grigoriadis KEpsilon, Angouras DC, Flevari A, Xathos T. Comparison of the Feasibility and Safety of Nasotracheal Suctioning With Curved Edge Catheter Versus Conventional Suction Catheter in Critically Ill Subjects: A Prospective Randomized Crossover Trial. Respir Care. 2015 Dec;60(12):1826-33. doi: 10.4187/respcare.03875. Epub 2015 Oct 20.

    PMID: 26487746DERIVED

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Results Point of Contact

Title
Mr. Konstantinos Grigoriadis ICU Physical Therapist
Organization
"Attikon" General University Hospital of Athens
grigoriakost@gmail.com
00302105832489

Study Officials

  • Dimitrios Angouras, MD

    Athens University School of Medicine, Department of Cardiothoracic Surgery

    STUDY DIRECTOR

  • Theodoros Xanthos, MD

    Athens University School of Medicine, Postgraduate program in CPR (moderator)

    STUDY DIRECTOR

  • Konstantinos Grigoriadis, PT

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

  • Katerina Flevari, MD

    Attikon Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 10, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 17, 2015

Results First Posted

March 17, 2015

Record last verified: 2015-03